BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEBAND® LOAD-DISTRIBUTING BAND

    MDR report key: 19768131 · Received July 17, 2024

    Report

    Report Number
    3010617000-2024-00555
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 22, 2024
    Report Date
    July 17, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    UDI-DI
    00849111001571
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE BELT GUARDS ON THE SIDE OF THE AUTOPULSE LIFEBAND (LOT# 181831) CAME UNLOCKED AND WOULD NOT CLICK BACK WAS NOT CONFIRMED DURING THE VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED LIFEBAND. DURING TESTING, NO DEVICE MALFUNCTION WAS FOUND, AND THE LIFEBAND FUNCTIONED APPROPRIATELY AND AS INTENDED. FUNCTIONAL TESTING OF THE RETURNED LIFEBAND WAS PERFORMED USING A KNOWN GOOD AUTOPULSE PLATFORM AND THE PLATFORM OWNED BY THE CUSTOMER. THE INSTALLATION TEST WAS SUCCESSFUL. THE LIFEBAND CLIP AND BELT GUIDE LOCKING TABS LOCKED CORRECTLY, AND THE HINGED BELT GUIDES SNAPPED INTO POSITION PROPERLY. THE PLATFORM PASSED A 30-MINUTE TEST ON A NORMAL MANIKIN, WITH ALL LIFEBAND PARTS FUNCTIONING CORRECTLY.

    Description of Event or Problem · 0

    DURING THE CALL, THE STAFF MEMBER WAS INFORMED THAT THE BELT GUARDS ON THE SIDE OF THE AUTOPULSE LIFEBAND (LOT# 181831) CAME UNLOCKED AND WOULD NOT CLICK BACK. THE CREW HAS DECIDED TO REMOVE THE DEVICE AND REPLACE IT WITH LUCAS TO PERFORM COMPRESSIONS. NO CONSEQUENCES OR IMPACT TO THE PATIENT. WHEN THE PLATFORM WAS REMOVED FROM THE PATIENT, THE BLACK COVER PLATE OF THE LIFEBAND CAME LOOSE, HOWEVER, THE LIFEBAND BELT CLIP WAS STILL IN THE SLOT OF THE DRIVE SHAFT. AFTER THE CALL, THE STAFF MEMBER CHANGED THE LIFEBAND AND DID NOT SEE ANY ERRORS ON THE DEVICE. THE DEVICE WAS TESTED OVER THE WEEKEND AND CONFIRMED TO BE FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366474 LIFEBAND® LOAD-DISTRIBUTING BAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION, INC. 100 181831 00849111001571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown