BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET GMBH

    MDR report key: 737410 · Received July 7, 2006

    Report

    Report Number
    8010652-2006-00007
    Event Type
    Other
    Date Received
    July 7, 2006
    Report Date
    June 8, 2006
    Manufacturer
    MAQUET GMBH AND CO KG
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF TABLE REVEALED THAT THE FIBERGLASS SLEEVE JAMMED UP AGAINST THE BASE AROUND THE WHEEL COVERS AND CRACKED. THE TABLE WAS CRATED AND RETURNED FOR FURTHER EVALUATION. AWAITING SECONDARY EVALUATION RESULTS.

    Description of Event or Problem · 1

    WHILE PERFORMING A PROCEDURE WITH THE OR TABLE IN REVERSE TRENDELENBURG POSITION, THE TABLE WAS LOWERED CAUSING A LOUD CRACKING NOISE AND GRINDING SOUNDS. PT WAS NOT INJURED AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET GMBH OR TABLE FQO MAQUET GMBH AND CO KG 1133.12F3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN