BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LIFEBAND

    MDR report key: 12686578 · Received October 23, 2021

    Report

    Report Number
    3010617000-2021-00955
    Event Type
    Malfunction
    Date Received
    October 23, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 22, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111065016
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFEBAND (LOT # 161862) USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. PROVIDED PICTURE OF THE LIFEBAND CONFIRMS THE PHYSICAL DAMAGE, HOWEVER, THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING PATIENT USE, THE AUTOPULSE PLATFORM STOPPED COMPRESSION DUE TO THE DAMAGED HINGED BELT GUARD ON LIFEBAND #1 (LOT# 161862). THE CUSTOMER REPLACED THE LIFEBAND, HOWEVER, AFTER 5 MINUTES OF USE, THE ALIGNMENT TAB ON THE LIFEBAND #2 (LOT# 161862) GOT BROKEN DURING THE COMPRESSION. THE OBSERVED ALIGNMENT TAB ISSUE DID NOT AFFECT THE FUNCTION OF THE PLATFORM AND THE PLATFORM CONTINUED THE COMPRESSIONS WITHOUT STOPPING. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584712 AUTOPULSE LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION MODEL 100 161862 00849111065016

    Patients

    Seq Age Sex Outcome Treatment
    1