MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-30 for AMSCO 3085 SP * manufactured by Steris Corporation.
[21800822]
Patient prepped and ready to start incision, table would not move. Assistant manager called to room, then biomed. Table could not be fixed. New table brought into room and patient transferred over, re-prepped and draped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4938564 |
| MDR Report Key | 4938564 |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-02-10 |
| Report Date | 2015-06-30 |
| Date Reported to FDA | 2015-06-30 |
| Date Reported to Mfgr | 2015-07-24 |
| Date Added to Maude | 2015-07-24 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | AMSCO |
| Generic Name | SURGICAL TABLE |
| Product Code | FSE |
| Date Received | 2015-06-30 |
| Model Number | 3085 SP |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD. MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-30 |