FDA Adverse Event
Malfunction
Summary report: N
OPERON
MDR report key: 2401431
·
Received December 30, 2011
Report
- Report Number
- 8010153-2011-00004
- Event Type
- Malfunction
- Date Received
- December 30, 2011
- Date of Event
- October 27, 2011
- Report Date
- December 27, 2011
- Manufacturer
- BERCHTOLD GMBH & CO. KG
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TABLE WAS EVALUATED BY A BERCHTOLD CORP. SERVICE TECHNICIAN ON (B)(4) 2011 AFTER THE INCIDENT AT THE LOCATION WHERE THE INCIDENT OCCURRED. THE TILTING PROBLEM WAS DUPLICATED, ALTHOUGH IT WAS INTERMITTENT. THE ROOT CAUSE WAS NOT DETERMINED AND THE TABLE WAS REMOVED FROM SERVICE AND REPLACED. THE TABLE WILL BE RETURNED TO THE BERCHTOLD CORPORATION FACILITY IN (B)(6) FOR FURTHER EVALUATION.
Description of Event or Problem · 1
AT THE COMPLETION OF A SURGICAL PROCEDURE, WHILE THE TABLE WAS BEING REPOSITIONED TO A LEVEL POSITION VIA THE RETURN TO LEVEL BUTTON, THE TABLE TILTED RIGHT. THE PATIENT STARTED TO FALL OFF THE TABLE BUT WAS CAUGHT BY OPERATING ROOM PERSONNEL. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERON | SURGICAL TABLE | FQO | BERCHTOLD GMBH & CO. KG | D820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |