MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-09 for AIRWAY PRESSURE MONITOR WITH ALARM 302220 OEM MONAHAN 332259 manufactured by Respironics.
[13401]
Mother returned my call (i had been unable to reach family for many days) on 10/18/94 and told me that the pt had died last night (10/17/94) in the hospital. She said she couldn't tell me what had happen but that it started at home and when they got to the hospital the t was clinically brain dead. She said theere was going to be an investigation & wanted our equipment left at home. She also said it was not our fault or the equipment's fault & not to worry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 36222-1994-09001 |
| MDR Report Key | 23464 |
| Date Received | 1994-12-09 |
| Date of Report | 1994-10-26 |
| Date of Event | 1994-10-17 |
| Date Facility Aware | 1994-10-18 |
| Report Date | 1994-10-26 |
| Date Reported to FDA | 1994-10-26 |
| Date Reported to Mfgr | 1994-10-26 |
| Date Added to Maude | 1995-07-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRWAY PRESSURE MONITOR WITH ALARM |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 1994-12-09 |
| Model Number | 302220 OEM MONAHAN |
| Catalog Number | 332259 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23747 |
| Manufacturer | RESPIRONICS |
| Manufacturer Address | 1001 MURRAY RIDGE DRIVE MURRYSVILLE 3 PA 156688550 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1994-12-09 |