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Medical device incident reports 01/10/2007- 31/12/2007

Number received: 303

Cause of problem1
Component failure 7
Contamination 1
Design 18
Electrical 10
Inadequate Instructions 1
Labelling 3
Maintenance 2
Manufacture 12
Material/Formulation Deficiency 5
Mechanical 31
Not Device Related 41
Other 51
Packaging/Sterility 2
Quality Assurance 5
Unknown 105
Wear/Deterioration 13
Effect
Death 10
Serious Injury 87
Temporary Injury 79
No Injury 127
Source category
Medical Administrator 6
Specialist 10
Nurse 18
Blood Bank 3
Hospital Supply Service 10
Other 22
Overseas Advice 1
Sponsor 209
Biomed Engineer 7
Para Medical 1
Patient/User 2
Coroner 1
Dentist 1
Result of investigation
Bulletin article 1
Company warned 0
Compliance testing 3
No Further Action 41
Not Investigated2 204
Other 21
Problem Not Confirmed 9
Product Improvement 10
Recall/Hazard Alert 5
Safety Alert 4
User Education 14

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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