MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-03 for OPERON B-810 B 810 * manufactured by Berchtold Corp.
[349927]
The bed, an operon b810, did not maintain proper position due to a malfunction in the hydraulic pressure system (most likely an "o" ring problem as per the manufacturer, the berchtold co. ) the patient nearly fell off of the bed. The patient's surgical procedure had to be cancelled as a result of the bed malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 501562 |
| MDR Report Key | 501562 |
| Date Received | 2003-12-03 |
| Date of Report | 2003-10-01 |
| Date of Event | 2003-10-01 |
| Date Added to Maude | 2003-12-19 |
| 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 | 3 |
| 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 | OPERON B-810 |
| Generic Name | SURGICAL TABLE |
| Product Code | FWY |
| Date Received | 2003-12-03 |
| Model Number | B 810 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 490354 |
| Manufacturer | BERCHTOLD CORP |
| Manufacturer Address | 1950 HANAHAN ROAD CHARLESTON SC 29406 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-03 |