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Medical device incident reports 01/07/2007 - 30/09/2007

Number received: 340

Cause of problem1
Component failure 11
Contamination 5
Design 25
Electrical 15
Inadequate Instructions 11
Labelling 3
Maintenance 3
Manufacture 35
Material/Formulation Deficiency 12
Mechanical 40
Not Device Related 60
Other 63
Packaging/Sterility 3
Quality Assurance 16
Unknown 118
Wear/Deterioration 24
Effect
Death 13
Serious Injury 83
Temporary Injury 102
No Injury 216
Source category
Medical Administrator 13
Specialist/Clinician 22
Nurse 39
Blood Bank 8
Hospital Supply Service 32
Other 25
Sponsor 258
Overseas Advice 1
Biomed Engineer 8
Para Medical 3
Patient/User 7
Dentist 1
Coroner 1
Result of investigation
Bulletin article 3
Company warned 1
Compliance testing 7
No Further Action 99
Not Investigated2 236
Other 20
Problem Not Confirmed 15
Product Improvement 23
Recall/Hazard Alert 10
Safety Alert 8
User Education 16

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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