MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-02-17 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..
[20244172]
Info was received that a pt expired while using the device. Report alleged that the pt's family member was awakened by a change in the sound of the concomitant device and that no alarm reportedly sounded. The report alleges that the pt was discovered to be not breathing and was later pronounced dead. Despite attempts to obtain additional info, none has been made available. Additional pt history and a copy of the coroner's report are unk. The equipment and alarm settings at the time of the event are unk. An eval of the unit has not been performed at this time and efforts to obtain the equipment have been unsuccessful. It is unk at this time whether a device failure had actually occurred, and whether there was any association between the use of the device and the pt's outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2005-00012 |
| MDR Report Key | 573615 |
| Report Source | 08 |
| Date Received | 2005-02-17 |
| Date of Report | 2005-01-18 |
| Date of Event | 2003-11-16 |
| Date Mfgr Received | 2005-01-18 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 2005-02-18 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID VANELLA |
| Manufacturer Street | 1001 MURRY RIDGE LN |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRWAY PRESSURE MONITOR |
| Generic Name | MONITOR, AIRWAY PRESSURE |
| Product Code | CAP |
| Date Received | 2005-02-17 |
| Model Number | 332259 |
| Catalog Number | 332259 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 563483 |
| 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 | 2005-02-17 |