MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-10-26 for OPERON D850 3260-065 manufactured by Berchtold Gmbh & Co. Kg.
[19105052]
During a surgical procedure with a patient on the table, the table was reported to have moved into tilt and unlocked with no activation of the hand control. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[19219466]
The table was evaluated by a berchtold field service representative on (b)(4) 2012. The problems could not be duplicated when using the original hand control, the replacement hand control, and the service program. The original hand control exhibited signs of damage, was replaced, and was returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010153-2012-00009 |
| MDR Report Key | 2843846 |
| Report Source | 06,07 |
| Date Received | 2012-10-26 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-09-05 |
| Date Mfgr Received | 2012-09-12 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2013-02-04 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Manufacturer G1 | BERCHTOLD GMBH |
| Manufacturer Street | LUDWIGSTALER STR. 25 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| 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 | 2012-10-26 |
| Model Number | D850 |
| Catalog Number | 3260-065 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD GMBH & CO. KG |
| Manufacturer Address | LUDWIGSTALER STR. 25 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-26 |