MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-24 for AMSCO 3085 SP * manufactured by Steris Corporation.
[17129676]
The steris 3085sp plastic ac connector that fits into the ac plate assembly, steris part # p134469339, is held into place by virtue of 2 plastic arms, one on either side of the connector. In time, with the plugging in and unplugging of the ac power cord into the connector, one of the plastic arms can break away causing the ac connector to pivot like a hinge on the other arm. We have seen 3 of these go bad over the course of 5 months on 3 different surgical tables. The concern is with the durability and the reliability of the single plastic arm on either side holding these ac connectors in place. ======================manufacturer response for surgical table, steris surgical table (per site reporter)======================they said they have never heard of this problem before. What was the original intended procedure? Use of surgical tabledevice #1is this a laboratory device or laboratory test? No
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3131009 |
| MDR Report Key | 3131009 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-05-24 |
| Date of Event | 2013-04-01 |
| Report Date | 2013-05-24 |
| Date Reported to FDA | 2013-05-24 |
| Date Reported to Mfgr | 2013-05-28 |
| Date Added to Maude | 2013-05-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TABLE |
| Product Code | BWN |
| Date Received | 2013-05-24 |
| Model Number | 3085 SP |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| 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 | 2013-05-24 |