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Medical device incident reports 01/01/2009 - 31/03/2009

4 June 2009

Number received: 296

Cause of problem1
Component failure 17
Contamination 2
Design 11
Electrical 36
Inadequate Instructions 7
Labelling 4
Maintenance 2
Manufacture 6
Material/Formulation Deficiency 9
Mechanical 118
Not Device Related 31
Other 13
Packaging/Sterility 1
Quality Assurance 11
Unknown 36
Wear/Deterioration 3
Effect
Death 8
Serious Injury 123
Temporary Injury 66
No Injury 99
Source category
Medical Administrator 1
Specialist 13
General Practitioner 1
Nurse 30
Blood Bank 0
Hospital Supply Service 2
Other 26
Sponsor 203
Overseas Advice 0
Biomed Engineer 10
Para Medical 4
Patient/User 6
Dentist 0
Coroner 0
Result of investigation
Bulletin article 2
Company warned 0
Compliance testing 7
No Further Action 90
Not Investigated2 162
Other 8
Problem Not Confirmed 5
Product Improvement 17
Recall/Hazard Alert 13
Safety Alert 2
User Education 11

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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