BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUCHES

    MDR report key: 2630804 · Received May 13, 2012

    Report

    Report Number
    3003984900-2012-00022
    Event Type
    Malfunction
    Date Received
    May 13, 2012
    Report Date
    May 14, 2012
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. - AKRON
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLAINT NUMBER: (B)(4). THE DEVICE HAS INSPECTED AT THE USER'S FACILITY BY A REPRESENTATIVE OF THE FORMER DISTRIBUTOR AND PHOTOS HAVE BEEN TAKEN, NOT A DIRECT EMPLOYEE OF ARJOHUNTLEIGH. IT APPEARS THAT THERE HAS BEEN A PARTIAL FAILURE OF THE WELD ON ONE OF THE "H" SECTION FABRICATIONS (PART NO. (B)(4). THE WELD APPEARS TO HAVE FAILED PARTIALLY ALONG ONE EDGE OF A FLANGE PLATE. FURTHER PHOTOGRAPHS HAVE BEEN REQUESTED TO CONFIRM FAILURE. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER HAS NOTICED A WELD HAS BROKE ON THE TOP FRAME AND IS VERY WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUCHES PPT-MEDICAL BEDS FMS HUNTLEIGH HEALTHCARE LTD. - AKRON 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other