BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-VAC VACUUM IMMOBILIZATION BAG

    MDR report key: 4450872 · Received January 19, 2015

    Report

    Report Number
    MW5040362
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 19, 2015
    Manufacturer
    CFI MEDICAL SOLUTIONS
    Product Code
    FZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NO MANUFACTURER INSTRUCTIONS OR RECOMMENDATIONS FOR STORAGE. WHEN NOT IN USE AT OUR FACILITY, THE IMMOBILIZER WAS FASTENED AROUND THE HAND PUMP THAT ACCOMPANIES THE PRODUCT AND STORED ON A SHELF IN AN UPRIGHT POSITION. WHEN NEEDED FOR INFANT MRI ON (B)(6) 2015, THE IMMOBILIZER WAS REMOVED FROM STORAGE, SECURED WITH STRAPS AROUND THE INFANT AND THE MED-VAC HAND PUMP WAS USED TO EVACUATE AIR FROM THE IMMOBILIZER. WHEN ALL AIR WAS REMOVED USING THE PUMP, THE AREA OF THE IMMOBILIZER SURROUNDING THE INFANT'S HEAD/NECK WAS NOT AS RIGID AS THE LOWER PORTION. AFTER REMOVAL FROM INFANT IT WAS NOTED THAT FEWER BEADS WERE DISTRIBUTED IN THE AREA NEAR THE UPPER SECTION THAT SURROUNDS THE INFANT'S HEAD/NECK AREA. IMMOBILIZER WAS THEN SHAKEN TO REDISTRIBUTE BEADS EVENLY THROUGHOUT AND TESTED WITH FINDINGS OF GREATER RIGIDITY IN HEAD/NECK AREA. IMMOBILIZER WILL NO LONGER BE STORED IN UPRIGHT POSITION AND WILL BE CHECKED PRIOR TO EACH USE TO INSURE THAT BEADS ARE EVENLY DISTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44056 MED-VAC VACUUM IMMOBILIZATION BAG IMMOBILIZER FZF CFI MEDICAL SOLUTIONS VMR 433X01 27035

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA