BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT HELPER ADAPTER (HEIGHT ADJ)

    MDR report key: 2521021 · Received April 4, 2012

    Report

    Report Number
    1035617-2012-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 7, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    ILZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SLEEVE SECTION OF THE PT HELPER BENT WHERE IT ATTACHES TO THE BED BRACKET. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE PT HELPER HAD BEEN ON THE PT'S BED PROVIDING TRAPEZE USE FOR QUITE SOME TIME. THE RN STATED THE PT WAS CONSIDERED TO BE QUITE PROACTIVE WITH PHYSICAL THERAPY AND SELF EXERCISE TO REGAIN LIMB FUNCTION AND STRENGTH. THE RN STATED THE PT WAS "DOING CHIN-UPS ON THE TRAPEZE, LIFTING HIS FULL BODY WEIGHT COMPLETELY OFF THE BED, WHEN THE PT NOTED THE BAR TO BE BENDING SLIGHTLY OVER THE BED." THE RN STATED THE PT WAS NOT HARMED AND NEITHER THE TRAPEZE NO THE PT HELPER FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT HELPER ADAPTER (HEIGHT ADJ) PATIENT HELPER ADAPTER (HEIGHT ADJ) ILZ ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1