BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARMBOARD

    MDR report key: 883670 · Received July 17, 2007

    Report

    Report Number
    2921578-2007-00005
    Event Type
    Other
    Date Received
    July 17, 2007
    Report Date
    July 17, 2007
    Manufacturer
    UNK
    Product Code
    ILE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS REQUESTED TO PURCHASE THE CORRECT SIDE RAIL ADAPTER (5855-830) AND WAS REQUESTED TO PERFORM REGULAR MAINTENANCE ON PRODUCT BEFORE EACH USE. THE SIDE RAIL ADAPTER WAS PURCHASED.

    Description of Event or Problem · 1

    ACCORDING TO THE OSI SALES REPRESENTATIVE CONVERSATION WITH THE HOSPITAL, THE HOSPITAL HAD BEEN USING AN OLDER IMAGING TOP WITH ANOTHER MEDICAL COMPANY'S ARMBOARDS WITHOUT THE SUGGESTED MIZUHO ORTHOPEDIC SYSTEMS SIDE RAIL ADAPTER. THE ARMBOARDS ATTACHMENT CLAMPS WAS ALSO WORN. THE USE OF THE DEVICE CAUSED THE CARBON SIDE RAILS TO BECOME DAMAGED. THE PATIENTS ARM MOVED PAST THE WORN DEVICES AND CAUSED THE PATIENTS HUMEROUS TO BECOME BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMBOARD ARMBOARD ILE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention MIZUHO ORTHOPEDIC SYSTEMS 350LB IMAGING TOP