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Medical device incident reports 1/01/2008 - 31/03/2008

Number received: 243

Cause of problem1
Biocompatibility 1
Component failure 7
Design 13
Electrical 16
Inadequate instructions 7
Manufacture 23
Material/formulation deficiency 3
Mechanical 14
Not device related 32
Other 23
Packaging/sterility 1
Quality assurance 6
Unknown 91
Wear/deterioration 16
Effect
Death 33
Serious injury 127
Temporary injury 63
No injury 20
Source category
Medical administrator 3
Specialist 6
Nurse 6
Hospital supply service 26
Other 17
Sponsor 183
Clinical technician 2
Patient/user 3
Technical 4
Competitor 1
Clinician 7
General practice 1
Hospital based 6
Result of investigation
Bulletin article 2
Other 9
No further action 35
Not investigated2 169
Product improvement 16
Recall/hazard alert 6
Safety alert 7
Problem not confirmed 4

Notes

  1. The problem causes are not mutually exclusive. For example, a material deficiency may have led to a mechanical malfunction or a biocompatibility problem.
  2. Every report received by IRIS receives a risk analysis by the Scheme Coordinator and is discussed by a panel of technical and clinical professionals. In the case of reports that are "Not Investigated" the panel has made a decision that further investigation of the particular event is not necessary at that time. However, these reports are logged into the database for future reference and the trend of reports is monitored. In making their decision, the panel considers whether any similar reports have been received previously.

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