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Medical device incident investigations, November 2007

9 November 2007

Sleep apnoea (CPAP and VPAP) devices being used as ventilators

The Therapeutic Goods Administration continues to receive reports that CPAP and VPAP devices are being used as life support units, especially for elderly patients. In one reported case, a patient was "turning blue and nearly died" when their VPAP device stopped when it over heated. The over heat alarm was triggered. Another report concerns a patient who was totally dependent on the device complaining about the lack of a power backup system in case of power failure. The patient claims that he would die if the machine stopped. A third report was about a hospital using one of these devices as a life support patient ventilator when it stopped working due to a motor bearing failure. In that case, the patient was hand ventilated until replacement unit was obtained.

The CPAP and VPAP devices manufactured by several manufacturers are non-continuous ventilators intended to augment the ventilation of patients who have restrictive or obstructive respiratory disorders and require non-continuous ventilator support. Examples of such respiratory disorders are obstructive sleep apnoea, chronic obstructive pulmonary disease, neuromuscular and chest wall diseases. The Clinical and Operating Manuals state that these devices are not intended to be used as life support ventilators. They may stop operating due to a power failure or if a fault occurs in the product.

Recommendations:

The TGA emphasises that the use of CPAP and VPAP ventilators for life support is in breach of the manufacturers' intended purpose and may lead to a serious adverse event. The units lack appropriate alarms and backup modes normally required for life supporting patient ventilators.

Statistics report

Device incident reports 01/07/2007 to 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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