MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-03 for OPERON B 810 manufactured by Berchtold Corp..
[1890202]
The data and info contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting. This mdr is based on preliminary info rec'd by berchtold, who has not conclusively determined the cause of the event. This mdr is, therefore, not intended to and shall not constitute an admission that a reportable event occurred or that any berchtold products were causally related to the event. During a procedure with a reverse oriented pt on the table in trendelenburg, the table was activated to move into the reverse trendelenburg position. During this movement, the back section started to move down without being activated, and hydraulic fluid was noted to be on the floor. At this time, the table stopped responding to commands. The pt was moved onto another table and the procedure was completed. No injury resulted from this product problem.
Patient Sequence No: 1, Text Type: D, B5
[8989384]
The table was evaluated by a berchtold svc rep on-site. The back-up hydraulic line got caught on the upper trend cylinder fitting, and while the table was moving, it pulled on the back-up hydraulic manifold connection, which resulted in a hydraulic leak that allowed the back section to drift down. The hydraulic line was replaced and the table was tested to be functioning properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220685-2011-00001 |
| MDR Report Key | 2035908 |
| Report Source | 07 |
| Date Received | 2011-03-03 |
| Date of Report | 2011-03-02 |
| Date of Event | 2011-02-07 |
| Date Mfgr Received | 2011-02-08 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2011-04-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS MANNARINO |
| Manufacturer Street | 1950 HANAHAN RD. |
| Manufacturer City | CHARLESTON SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal | 29406 |
| Manufacturer Phone | 8002435135 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERON |
| Generic Name | SURGICAL TABLE |
| Product Code | FWY |
| Date Received | 2011-03-03 |
| Model Number | B 810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD CORP. |
| Manufacturer Address | CHARLESTON SC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-03 |