MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-01 for OXIMAX N-595 manufactured by Nellcor Puritan Bennett Inc.
[314679]
The alarm speaker on the device failed. The site had been notified by the manufacturer of this possibility, but in their letter they stated that their anticipated rate of failure would be "less than two tenths of one percent of the installed instrument base" the site have experienced three failures out of the 140 devices that they own. This is a significantly higher rate than expressed by the manufacturer. They feel that a failure rate of this magnitude should fall into the category of a mandatory recall. Loss of alarms is too critical to facility's patients. Follow up reveals:the alarm on this model can be silenced, but it can not be turned off. When it is silenced, it automatically comes back on. This facility is continuing to have failures of this nature even after the initial reporting and the reporter has been made aware of additional incidences on the biomedical talk line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 558919 |
| MDR Report Key | 558919 |
| Date Received | 2004-12-01 |
| Date of Report | 2004-12-01 |
| Date of Event | 2004-11-26 |
| Report Date | 2004-12-01 |
| Date Reported to FDA | 2004-12-01 |
| Date Added to Maude | 2004-12-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | OXIMAX N-595 |
| Generic Name | OXYGEN SATURATION MONITOR |
| Product Code | LPP |
| Date Received | 2004-12-01 |
| Model Number | N-595 |
| Catalog Number | N-595 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548615 |
| Manufacturer | NELLCOR PURITAN BENNETT INC |
| Manufacturer Address | 4280 HACIENDA DR PLEASANTON CA 94588 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-01 |