MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-20 for ANESTHESIA MACHINE manufactured by North American Drager.
[19524]
Rptr received call from a surgery technician. He informed medical equipment repair of an apparent anesthesia machine malfunction. It had reportedly stopped delivering oxygen to the pt. They immediately switched to bottled oxygen without success. There are conflicting reports about whether the incoming oxygen gauge displayed proper pressure or not. In hopes of resolving the problem, a technician left the room to get a new bottle of oxygen; but, by the time he returned, the anesthesia machine had returned to normal operation. Since the procedure was nearly finished, the machine was used to finish the case. As soon as the case was completed the anesthesia machine was removed from service. A follow-up call on 2/9/96 revealed that the machine in question has operated perfectly since the initial problem was reported as have their other three units.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001108 |
| MDR Report Key | 31371 |
| Date Received | 1996-03-20 |
| Date of Report | 1996-01-10 |
| Date Added to Maude | 1996-03-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANESTHESIA MACHINE |
| Generic Name | ANESTHESIA MACHINE |
| Product Code | GSZ |
| Date Received | 1996-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32465 |
| Manufacturer | NORTH AMERICAN DRAGER |
| Manufacturer Address | 3122 COMMERCE DR TELFORD PA 18969 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-20 |