MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 1997-09-12 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..
[71691]
During evaluation and repair of returned device, it was noted that the low alarm would not trigger until the gauge was in the negative range, at about -10. The customer was then contacted for further info. The customer indicated that the problem was discovered during their internal testing. The deivice was not being used by a pt at the time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-1997-00019 |
| MDR Report Key | 119185 |
| Report Source | 01 |
| Date Received | 1997-09-12 |
| Date of Report | 1997-09-12 |
| Date of Event | 1997-08-13 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1997-09-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRWAY PRESSURE MONITOR |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 1997-09-12 |
| Model Number | 332259 |
| Catalog Number | 332259 |
| Lot Number | NA |
| ID Number | 30104-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 116851 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE DRIVE MURRYSVILLE PA 156688550 US |
| Baseline Brand Name | AIRWAY PRESSURE MONITOR |
| Baseline Generic Name | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| Baseline Model No | 332259 |
| Baseline Catalog No | 332259 |
| Baseline ID | NA |
| Baseline Device Family | MONITORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K902276 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-12 |