MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for AMSCO 3085-SP SURGICAL TABLE 3085 SP manufactured by Steris Corporation.
[173478016]
After patient was intubated, bed stopped working. It would not function at all, not even to unlock the bed. Biomed was notified and promptly came to the room. The bed was unable to be fixed. There was no manual unlock mechanism for the bed to get it out of the room. Biomed was slowly able to unscrew the bolt that locks the bed, and the bed had to be dragged out. The patient was asleep unnecessarily for over an hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9543276 |
| MDR Report Key | 9543276 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-09-17 |
| Report Date | 2019-12-16 |
| Date Reported to FDA | 2019-12-16 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO 3085-SP SURGICAL TABLE |
| Generic Name | ABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | FQO |
| Date Received | 2020-01-03 |
| Model Number | 3085 SP |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |