FDA Adverse Event
Other
Summary report: N
8010652-2008-00002
MDR report key: 1003713
·
Received February 14, 2008
Report
- Report Number
- 8010652-2008-00002
- Event Type
- Other
- Date Received
- February 14, 2008
- Product Code
- FQO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE PT WAS PREPPED FOR A C-SECTION AND HAD AN EPIDERMAL INSERTED. BEFORE ANY INCISIONS WERE MADE, THE TRENDELENURG CYLINDER SHAFT BROKE ALLOWING THE TABLE TO DROP BACK SUDDENLY INTO A TRENDELENBURG POSITION. THE PROCEDURE WAS STOPPED AND THE DOCTORS CONDUCTED AN EXAMINATION OF THE PT. NO INJURY OCCURRED DURING THIS EVENT. THE PT WAS TRANSFERRED TO ANOTHER OR TABLE AND THE SUBJECT TABLE WAS REMOVED FROM SERVICE. ROOT CAUSE IS ALREADY IDENTIFIED AND KNOWN. REPAIRS ARE PENDING WITH CUSTOMER. DISTRIBUTOR SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET GMBH & CO. KG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FQO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |