MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-04-08 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..
[370075]
Legal documentation received alleged that the device was in use by a tracheostomy patient in conjunction iwth a free-standing c-pap, including a heated humidifier, an oxygen analyzer monitor and an oxygen and air compressor. Cpap was being administered invasively. The information alleges that the patient's trach tube became dislodged and the subject device did not alarm at the time of the event. The patient was hospitalized and later reportedly expired form anoxic encephalopathy. Additional patient history and a copy of the coroner's report are unknown. The equipment and alarm settings at the time of the event are unknown. An evaluation of the unit has not been performed at this time and efforts to obtain the equipment have been unsuccessful. It is unknown at this time whether a device failure had actually occurred, and whether there was any association between the use of the device and the patient's outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2005-00028 |
| MDR Report Key | 589359 |
| Report Source | 00 |
| Date Received | 2005-04-08 |
| Date of Report | 2005-03-11 |
| Date of Event | 2003-03-03 |
| Date Mfgr Received | 2005-03-11 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 2005-04-11 |
| 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 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 | 2005-04-08 |
| Model Number | 332259 |
| Catalog Number | 332259 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NO INFORMATION |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 579208 |
| 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 | 2005-04-08 |