Medical device incident reports 01/04/2007 - 30/06/2007
Number received: 280
Total number of investigations completed: 238
Cause of problem1
| Component failure |
21 |
| Contamination |
1 |
| Design |
11 |
| Electrical |
16 |
| Inadequate Instructions |
3 |
| Labelling |
2 |
| Maintenance |
2 |
| Manufacture |
18 |
| Material/Formulation Deficiency |
12 |
| Mechanical |
20 |
| Not Device Related |
23 |
| Other |
25 |
| Packaging/Sterility |
2 |
| Quality Assurance |
6 |
| Unknown |
77 |
| Wear/Deterioration |
9 |
Effect
| Death |
9 |
| Serious Injury |
55 |
| Temporary Injury |
64 |
| No Injury |
110 |
Source category
| Medical Administrator |
4 |
| Specialist |
13 |
| Nurse |
8 |
| Blood Bank |
1 |
| Hospital Supply Service |
16 |
| Other |
2 |
| Biomed Engineer |
10 |
| Para Medical |
1 |
| Patient/User |
22 |
| Coroner |
1 |
| Sponsor |
181 |
| Overseas |
2 |
| Dentist |
1 |
Result of investigation
| Bulletin article |
2 |
| Company warned |
1 |
| Compliance testing |
1 |
| No Further Action |
43 |
| Not Investigated2 |
152 |
| Other |
7 |
| Problem Not Confirmed |
12 |
| Product Improvement |
13 |
| Recall/Hazard Alert |
7 |
| Safety Alert |
6 |
| User Education |
3 |
Notes
- The problem causes are not mutually exclusive. For example, a material deficiency may have led to a mechanical malfunction or a biocompatibility problem.
- 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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