MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-08 for REMSTAR M SERIES 500M * manufactured by Respironics.
[576096]
Use of respironics "m" series cpap/bipap machine. The pt was sent a cpap machine instead of a bipap machine. The pt looked at the bottom of the machine where the mfr's label states "m series" "remstar/ bipap. " so the pt used the machine for a period of time before contacting the mfr to verify what the device actually was. The pt was told that this was a cpap machine and not a bipap machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042202 |
| MDR Report Key | 827737 |
| Date Received | 2007-03-08 |
| Date of Report | 2007-03-08 |
| Date of Event | 2007-03-07 |
| Date Added to Maude | 2007-03-16 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMSTAR M SERIES |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2007-03-08 |
| Model Number | 500M |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 815141 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | * MURRYSVILLE PA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-08 |