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Medical device incident reports 01/01/2007 - 31/03/2007

Number received: 206

Cause of problem1
Component failure 16
Contamination 1
Design 12
Electrical 15
Inadequate Instructions 2
Labelling 9
Maintenance 3
Manufacture 12
Material/Formulation Deficiency 9
Mechanical 11
Not Device Related 19
Other 38
Packaging/Sterility 1
Quality Assurance 3
Unknown 66
Wear/Deterioration 9
Effect
Death 7
Serious Injury 26
Temporary Injury 74
No Injury 99
Source category
Medical Administrator 4
Specialist 9
Nurse 14
Blood Bank 5
Hospital Supply Service 9
Other 17
Sponsor 123
Overseas Advice 1
Biomed Engineer 9
Para Medical 1
Patient/User 4
Dentist 0
Coroner 0
Result of investigation
Bulletin article 1
Company warned 2
Compliance testing 2
No Further Action 55
Not Investigated2 117
Other 4
Problem Not Confirmed 2
Product Improvement 16
Recall/Hazard Alert 5
Safety Alert 3
User Education 6

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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