Jump to top navigation | Jump to main navigation | Jump to content
Therapeutic Goods Administration logo

Medical device incident reports 01/04/2008 - 30/06/2008

Number received: 279

Cause of problem1
Component failure 12
Contamination 0
Design 7
Electrical 27
Inadequate Instructions 11
Labelling 3
Maintenance 3
Manufacture 30
Material/Formulation Deficiency 20
Mechanical 28
Not Device Related 55
Other 17
Packaging/Sterility 4
Quality Assurance 14
Unknown 71
Wear/Deterioration 8
Effect
Death 8
Serious Injury 56
Temporary Injury 95
No Injury 130
Source category
Medical Administrator 11
Specialist 6
General Practitioner 5
Nurse 19
Blood Bank 4
Hospital Supply Service 14
Other 10
Overseas Advice 3
Sponsor 198
Biomed Engineer 10
Para Medical 1
Patient/User 6
Coroner 2
Dentist 0
Result of investigation
Bulletin article 3
Company warned 0
Compliance testing 0
No Further Action 54
Not Investigated2 168
Other 12
Problem Not Confirmed 11
Product Improvement 23
Recall/Hazard Alert 6
Safety Alert 4
User Education 21

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.

Top of page