MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-02-06 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..
[357621]
Info was received regarding an allegation that medical equipment supplied to a pt was dfectively provided and/or maintained and otherwise malfunctioned and/or became inoperative while in pt use. The alleged problem with the equipment occurred on or about 3/2000 proximately causing the death of the pt two days later. It is unclear which of the products allegedly malfunctioned. It is unclear if the equipment was in pt use at the time of death. Prior to this event, the unit was returned for service in 11/1999 and was returned to the customer operating to specification. After this event, the unit was returned for routine service in 8/2000. There was no report of pt harm at that time. During the repair eval, it was discovered that the gauge had been over-pressured. The gauge was replaced to correct the problem and the unit was returned to the customer operating to specification. The equipment is not currently available for investigation. The alarm settings at the time of the alleged malfunction are unk. It is unk at this time whether a device failure had actually occurred and if so, whether there was any association between any such failure and the pt expiring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2004-00005 |
| MDR Report Key | 510136 |
| Report Source | 00 |
| Date Received | 2004-02-06 |
| Date of Report | 2004-01-08 |
| Date of Event | 2000-03-22 |
| Date Mfgr Received | 2004-01-08 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 2004-02-09 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID VANELLA |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15866 |
| Manufacturer Country | US |
| Manufacturer Postal | 15866 |
| Manufacturer Phone | 7247335866 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRWAY PRESSURE MONITOR |
| Generic Name | MONITOR, AIRWAY PRESSURE (INCLUDING GAUGE AND/OR ALARM) |
| Product Code | CAP |
| Date Received | 2004-02-06 |
| Returned To Mfg | 2000-08-03 |
| Model Number | 332259 |
| Catalog Number | 332259 |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 499103 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LN 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 | 1. Death | 2004-02-06 |