MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-14 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..
[54991]
Device was being tested prior to use on a patient after being in storage for an undetermined amount of time. Testing by the facility indicated that servicing was required on the device because of "no low alarm control, and a missing ring from the switch. " device was returned for servicing. During servicing, it was determined that the alarm was not functional. Device was not on a patient at the time of the reported problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-1997-00008 |
| MDR Report Key | 91070 |
| Report Source | 06 |
| Date Received | 1997-05-14 |
| Date of Report | 1997-05-13 |
| Date of Event | 1997-04-14 |
| Report Date | 1997-05-14 |
| Device Manufacturer Date | 1992-06-01 |
| Date Added to Maude | 1997-05-16 |
| 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 | 1997-05-14 |
| Returned To Mfg | 1997-04-11 |
| Model Number | 332259 |
| Catalog Number | 332259 |
| Lot Number | NA |
| ID Number | 26924-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 89974 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE DR. 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 | 1997-05-14 |