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Medical device incident reports 01/04/2009 - 30/06/2009

10 July 2009

Number received: 630

Cause of problem1
Component failure 26
Contamination 6
Design 23
Electrical 130
Inadequate Instructions 4
Labelling 3
Maintenance 2
Manufacture 11
Material/Formulation Deficiency 24
Mechanical 198
Not Device Related 43
Other 60
Packaging/Sterility 4
Quality Assurance 27
Unknown 82
Wear/Deterioration 12
Effect
Death 17
Serious Injury 474
Temporary Injury 91
No Injury 31
Source category
Medical Administrator 4
Specialist 12
General Practitioner 1
Nurse 35
Blood Bank 0
Hospital Supply Service 9
Other 21
Sponsor 497
Overseas Advice 1
Biomed Engineer 15
Para Medical 2
Patient/User 11
Dentist 1
Coroner 0
Result of investigation
Bulletin article 2
Company warned 1
Compliance testing 7
No Further Action 139
Not Investigated2 413
Other 14
Problem Not Confirmed 4
Product Improvement 28
Recall/Hazard Alert 15
Safety Alert 16
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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