MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-10 for STERIS 3085-SP manufactured by Steris Corporation.
[20892851]
Post anesthesia induction and prior to the start of an or procedure the patient was positioned supine on surgical table. Using the cable remote control the or bed was lowered at which time the table proceded to spontaneously flex and re-position patient in a higher position. An attempt to utilize the cable remote to stop the table from it's upward ascension was unsuccessful. The cable remote was finally disconnected, yet the bed continued upward until it was positioned at a 90 degree angle. The patient sustained no adverse effects. Recommend that company considers installing a "kill switch" safety net on all tables.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007239 |
| MDR Report Key | 1058386 |
| Date Received | 2008-06-10 |
| Date of Report | 2008-06-04 |
| Date of Event | 2008-06-03 |
| Date Added to Maude | 2008-06-17 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIS |
| Generic Name | STERIS (AMSCO) 3085 SP SURGICAL TABLE |
| Product Code | BWN |
| Date Received | 2008-06-10 |
| Model Number | 3085-SP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1027462 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD. MENTOR OH 44060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-10 |