MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-23 for AMSCO 2080 RC SURGICAL TABLE manufactured by Steris Corp..
[63010]
It was reported that with a pt on a 24-yr-old surgical table, and the table in a flex position, the back section would not return to a level position until other o. R. Personnel were able to manipulate the table until it reached a level position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-1997-00013 |
| MDR Report Key | 93696 |
| Report Source | 05,06 |
| Date Received | 1997-05-23 |
| Date of Report | 1997-04-25 |
| Date of Event | 1997-04-17 |
| Date Mfgr Received | 1997-04-25 |
| Device Manufacturer Date | 1973-01-01 |
| Date Added to Maude | 1997-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO 2080 RC SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | FSE |
| Date Received | 1997-05-23 |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 92495 |
| Manufacturer | STERIS CORP. |
| Manufacturer Address | 2720 GUNTER PARK DR. E. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-23 |