MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-30 for COMPRESSOR MINI COMPR MINI 115V 60HZ 6481779 manufactured by Maquet Critical Care Ab.
[189081147]
The compressor was investigated by our field service engineer. The compressor displayed alarm for low pressure and did not start. The integrated compressor with motor unit was replaced but not returned for investigation. The compressor passed all functional and safety tests per factory specifications, was returned to customer and cleared for clinical use. The root cause of the reported issue cannot be determined due to lack of goods.
Patient Sequence No: 1, Text Type: N, H10
[189081148]
It was reported that the compressor alarmed for low pressure and did not start. There was no patient harm. Manufacturer's ref #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2020-00057 |
| MDR Report Key | 9646459 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date Mfgr Received | 2019-06-03 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Manufacturer G1 | MAGNUS LINDQVIST |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSOR MINI |
| Generic Name | COMPRESSOR, AIR, PORTABLE |
| Product Code | BTI |
| Date Received | 2020-01-30 |
| Model Number | COMPR MINI 115V 60HZ |
| Catalog Number | 6481779 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | ROENTGENVAGEN 2 SOLNA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |