MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-06 for REMSTAR 1005960 manufactured by Remstar.
[694943]
Remstar cpap machine completely stopped operating, it would only light up when power was turned on. We took it to the medical office and tech couldn't fix machine and never replaced it or sent it for repair. Made several trips to get repair, etc. But had no luck, this went on for several months. In 2006, this cause was the cause of my husband's death. Frequency: nightly, route: inhale. Dates of use: 2004 - 2006. Diagnosis or reason for use: sleep apnea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003343 |
| MDR Report Key | 891743 |
| Date Received | 2007-08-06 |
| Date of Report | 2007-08-06 |
| Date of Event | 2006-09-18 |
| Date Added to Maude | 2007-08-20 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMSTAR |
| Generic Name | CPAP MACHINE/DEVICE |
| Product Code | NHJ |
| Date Received | 2007-08-06 |
| Model Number | 1005960 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873671 |
| Manufacturer | REMSTAR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-08-06 |