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Adverse Incidents Reporting PDF Print E-mail

The objective of the adverse event reporting is to improve protection of the health and safety of patients, users and others by disseminating information which may reduce the likelihood of, or prevent repetition of adverse events, or alleviate consequences of such repetition. 

Definition of “an event”*
a) A malfunction or deterioration in the characteristics or performance – A malfunction or deterioration should be understood as a failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer's instructions. The intended purpose means the use for which the device is intended according to the data supplied by the manufacturer on the labeling, in the instructions and/or in promotional materials.
b) An inadequate design or manufacture – This would include cases where the design or manufacturing of a device is found deficient.
c) An inaccuracy in the labeling, instructions for use and/or promotional materials – Inaccuracies include omissions and deficiencies. Omissions do not include the absence of information that should generally be known by the intended users.
d) A significant public health concern – This can include an event that is of significant and unexpected nature such that it becomes alarming as a potential public health hazard, e.g. human immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD). These concerns may be identified by either the NCA or the manufacturer.
e) Other information becoming available – This can include results of testing performed by the manufacturer on its products, or by the user prior to being used on the patient, or by other parties. This can also include information from the literature or other scientific documentation.

Criteria for Reportable Events
Any event, which meets all of three basic criteria listed below, is considered an adverse event reportable to the NCA:
a. An event has occurred OR a potential adverse event is recognized through information available
b. The manufacturer’s device is a contributing factor (OR potential contributing factor) to the event – In assessing the link between the device and the event, the manufacturer should take into account:
        i. The opinion, based on available information, from a healthcare professional;
        ii. Information concerning previous, similar events;
       iii. Other information held by the manufacturer.
This judgment may be difficult when there are multiple devices and drugs involved. In complex situations, it should be assumed that the device was associated with the event.
c. The event led to one of the following outcomes:
       i. Death of a patient, user or other person.
      ii. Serious injury of a patient, user or other person.
Serious injury (or serious deterioration in state of health) is either:
        • life threatening illness or injury.
        • permanent impairment of a body function or permanent damage to a body structure.
        • a condition necessitating medical or surgical intervention to prevent permanent
        • impairment of a body function or permanent damage to a body structure.
The interpretation of the term "serious” is not easy, and should be made in consultation with a medical practitioner when appropriate. The term “permanent” means irreversible impairment or damage to a body structure or function, excluding minor impairment or damage. Medical intervention is not in itself a serious injury. It is the reason that motivated the medical intervention that should be used to assess the reportability of an event.
     iii. No death or serious injury occurred but the event might lead to death or serious injury of a patient, user or other person if the event recurs (also known as “near incidents”; “near adverse event”)
The non-occurrence of a serious result might have been due to circumstances or to the timely intervention of healthcare personnel. The event is considered “adverse” if in the case of recurrence, it could lead to death or serious injury. This applies also if the examination of the device or a deficiency in the information supplied with the device, or any information associated with the device, indicates some factor that could lead to an event involving death or serious injury.

Examples of Reportable Adverse Events #
a) Loss of sensing after a pacemaker has reached end of life. Elective replacement indicator did not show up in due time, although it should have according to device specification.
b) On an X-ray vascular system during patient examination, the C arm had uncontrolled motion. The patient was hit by the image intensifier and his nose was broken. The system was installed, maintained, and used according to manufacturer’s instructions.
c) It was reported that a monitor suspension system fell from the ceiling when the bolts holding the swivel joint broke off. Nobody was injured in the surgical theatre at that time but a report is necessary (near incident). The system was installed, maintained, and used according to manufacturer’s instructions.
d) Sterile single use device packaging is labeled with the caution ‘do not use if package is opened or damaged’. The label is placed by incorrect design on inner packaging. Outer package is removed but device is not used during procedure. Device is stored with inner packaging only which does not offer a sufficient sterile barrier.
e) A batch of out-of-specification blood glucose test strips is released by manufacturer. Patient uses strips according to instructions, but readings provide incorrect values leading to incorrect insulin dosage, resulting in hypoglycemic shock and hospitalization.
f) Premature revision of an orthopedic implant due to loosening. No cause yet determined.
g) An infusion pump stops, due to a malfunction, but fails to give an alarm. Patient receives under-infusion of needed fluids and requires extra days in hospital to correct.
h) Manufacturer of a pacemaker released on the market identified a software bug. Initial risk assessment determined risk of serious injury as remote. Subsequent failure results in new risk assessment by manufacturer and the determination that the likelihood of occurrence of a serious injury is not remote.
i) Patients undergoing endometrial ablation of the uterus suffered burns to adjacent organs. Burns of adjacent organs due to thin uterine walls were an unanticipated side effect of ablation.
j) Manufacturer does not change ablation device label and fails to warn of this side effect which may be produced when the device is working within specification.
k) Healthcare professional reported that during implant of a heart valve, the sewing cuff is discovered to be defective. The valve was abandoned and a new valve was implanted and pumping time during surgery was extended.
l) During the use of an external defibrillator on a patient, the defibrillator failed to deliver the programmed level of energy due to malfunction. Patient died.
m) An intravenous set separates, the comatose patient’s blood leaks onto the floor, the patient bleeds to death.

Responding to concerns about medical devices

Healthcare professionals and their patients, as well as manufacturer and local representative (marketing authorisation holder), can report problems about medical devices to the MDB through the adverse incident reporting scheme.  The report can also be done online through this website.  These reports may help manufacturers to improve their product safety, design or product information.  They also help MDB to ensure and improve the safety of a medical device.
All reports will be assessed, and acted upon although the response will be graded, according to the seriousness of the incident and/or the potential for future harm.
Further information may be obtained before the response is determined, which may be :
    -  a Medical Device Alert - a device safety alert, giving advice to the healthcare service, or
    -  a product recall
    -  requirement for the manufacturer to make appropriate changes in design or information.

Other countries regulatory authorities statistic and reports also showed that the number of device reports has risen over the past decade.  Technology has become more complex and sophiscated, and patients and professionals have been encouraged to report problems.  The number of medical devices in use has also increased significantly over this period.

Positive effects

Increasing number of reporting also reflects a high level of awareness and therefore the effectiveness of the safety monitoring system.  It does not mean however that manufacturing standards have fallen or that devices have become less safe, overall.

If you are a patient, healthcare professional, or work for a medical device manufacturer and would like more information on the work of MDA, or if you would like to know how you can contribute to the safe use of medical device, please contact :

                               Chief Executive,
                               Medical Device Authority (MDA), Ministry of Health Malaysia,
                               Level 6, Prima 9, Prima Avenue II,
                               Block 3547, Persiaran APEC, 63000 Cyberjaya, Selangor, MALAYSIA

                               Tel: +603-8230 0300  | Fax : +603-8230 0200

                               E-mail  :  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

                               Contact Person: Mr Mohd Zulhisham  

* (Source SG2 N21R8)
# (Source SG2 N21R8)


Last Updated ( Sunday, 15 April 2018 )
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