BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAVIG

    MDR report key: 1080210 · Received July 15, 2008

    Report

    Report Number
    2438931-2008-00003
    Event Type
    Other
    Date Received
    July 15, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MAVIG. GMBH
    Product Code
    KPY
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARM WAS RETURNED TO US FOR EVALUATION ON JUNE 30TH. MEDWATCH-EQUIPMENT EVALUATION SUMMARY: FINDINGS: UPON RECEIPT OF THE BROKEN SUSPENSION ARM INVOLVED IN THE INCIDENT AT (B) (6) HOSPITAL, IT IS READILY APPARENT THAT THIS ARM HAS BEEN SEVERELY MISUSED BY THE HOSPITAL. THERE IS A GREAT DEAL OF PHYSICAL EVIDENCE, IN THE FORM OF DEEP SCRATCHING IN TO THE PAINT, WHICH SHOWS THERE HAVE BEEN NUMEROUS COLLISIONS WITH OTHER EQUIPMENT IN THE ROOM. THE EDGE SURFACES ARE SCRATCHED DOWN TO THE BARE METAL, LEAVING LITTLE OR NO PAINT IN MANY SECTIONS. THIS PAINT LOSS AND SCARRING INDICATES THAT THIS ARM HAS BEEN HIT REPEATEDLY, AND WITH FORCE, BY HEAVY FOREIGN OBJECTS (I.E. SUSPENDED LAMPS, SHIELDS, C-ARM, ETC...). CONCLUSION: BASED ON THE HOSPITAL'S ACCOUNT THAT THE DOCTOR WAS "FORCING THE ARM FREE FROM A STUCK POSITION" AND GIVEN THE PHYSICAL CONDITION OF THE ARM, IT IS OUR OPINION THAT THIS ARM WAS SIGNIFICANTLY WEAKENED BY ABUSE WHICH LEAD TO ITS FAILURE.

    Description of Event or Problem · 1

    HOSPITAL DESCRIBES THE EVENT AS FOLLOWS: THE DR WAS ATTEMPTING TO MOVE THE SHIELD ASSEMBLY AND REALIZED, IT WAS STUCK. HE FORCED THE ARM TO GET IT FREE OF OBSTRUCTION AND THE ASSEMBLY BROKE OFF. STRIKING HIM AS IT FEEL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVIG HANEL KPY MAVIG. GMBH 1624520

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other