BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 975590 · Received July 20, 2007

    Report

    Report Number
    8010652-2007-00002
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    June 19, 2007
    Report Date
    June 21, 2007
    Manufacturer
    MAQUET GMBH AND CO. KG
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION AT THE FACILITY FOUND MISALIGNED ACCESSORIES DUE TO LACK OF CARE AND HANDLING. EVAL RESULTED IN THE DISCOVERY THAT THE CUSTOMER IS NOT ENGAGING THE KNOBS THAT SECURE THE HEADREST (AS A LEVEL OF SAFETY). ALSO, UPON INSPECTION IT APPEARED AS THOUGH, THE HEADREST HAD BEEN DROPPED CAUSING THE PINS TO BECOME BENT AND MISALIGNED. NO FURTHER INFO ABOUT THE PT AND VERY LIMITED INPUT READING THE INCIDENT WAS OBTAINED DURING F/U VISITS AND QUESTIONING OF THE STAFF. THE ACCESSORIES WERE ADJUSTED TO WORK PROPERLY AND RE-TRAINING OF THE STAFF WAS DONE SHORTLY AFTER NOTIFICATION, REGARDING THE IMPORTANCE OF FOLLOWING MFR'S INSTRUCTIONS OF THE ACCESSORIES AND THEIR INTERFACING WITH THE OR TABLE. GETING USA, INC. 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.

    Description of Event or Problem · 1

    THE FACILITY WAS VISITED AND THERE WAS NO INFO ABLE TO BE GAINED ABOUT THE PT AND LIMITED INFO ABOUT THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET FQO FQO MAQUET GMBH AND CO. KG 1132.11B2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *