MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-25 for COMPRESSOR * manufactured by Kobelco Northwest.
[78537]
Compressor on hbo chamber did not work necessitating use of back-up. Pt was able to continue treatment in a successful effort to save amputated fingers. Failure of compressor has occurred several times over last few months. Failure seems to be related to sludge in the oil line possibly related to the chilled water system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011935 |
| MDR Report Key | 115040 |
| Date Received | 1997-08-25 |
| Date of Report | 1997-08-14 |
| Date of Event | 1997-08-03 |
| Date Added to Maude | 1997-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSOR |
| Generic Name | COMPRESSOR |
| Product Code | KPJ |
| Date Received | 1997-08-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 112923 |
| Manufacturer | KOBELCO NORTHWEST |
| Manufacturer Address | 14600 SOUTHWEST 72ND AVE. PORTLAND OR 97224 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-25 |