BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN BEACH CHAIR ARM PLATFORM

    MDR report key: 1725674 · Received June 11, 2010

    Report

    Report Number
    1221538-2010-00003
    Event Type
    Other
    Date Received
    June 11, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN ARM PLATFORM, WHICH HAD BEEN IN THE FIELD FOR NINE YEARS, WAS RETURNED AND EVALUATED BY AN ENGINEER. THERE ARE NO SIMILAR KNOWN ISSUES FOR THIS PRODUCT ON FILE. IT WAS CONFIRMED THAT THE 3 SCREWS AFFIXING THE BOARD TO THE POST AT THE BASE OF THE DEVICE HAD BROKEN. IT WAS UNCLEAR IF ONE OR MORE OF THE SCREWS OF THE UNIT HAD BROKEN PREVIOUS TO THE INCIDENT AND REMAINED IN USE - OR IF ALL THREE BROKE AT THE SAME TIME. THE CROSS SECTION OF THE SCREWS SHOW THAT THE MATERIAL DID NOT HAVE ANY VOIDS THAT COULD HAVE WEAKENED IT. (B)(4). THERE ARE NO APPARENT INDICATIONS ON ANY OTHER PART OF THE PRODUCT TO DISCERN THAT THIS TYPE OF A LOAD WAS EVER APPLIED TO THE PRODUCT. AS A RESULT, THE ENGINEER WAS UNABLE TO DISCERN ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, ALLEN MEDICAL'S REPAIR DEPARTMENT RECEIVED A REQUEST TO REPAIR A BROKEN ARM PLATFORM. THE REPORTER STATED THAT THE FAILURE HAPPENED DURING USE. THERE WAS NO INJURY. THE BOARD WAS REPLACED WITH ANOTHER ON SITE AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUE AND WITH ONLY A BRIEF DELAY. THERE WAS NO IMPACT TO THE CASE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN BEACH CHAIR ARM PLATFORM ALLEN ARM PLATFORM FWZ ALLEN MEDICAL SYSTEMS A-90007-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention