BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 18454749 · Received January 5, 2024

    Report

    Report Number
    3010617000-2024-00018
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Report Date
    February 16, 2024
    Manufacturer
    ZOLL CIRCULATION
    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

    ZOLL HAS NOT RECEIVED THE LIFEBAND (LOT #181831) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF AND WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING THE DEVICE CHECK, THE CUSTOMER REPORTED THAT THE LIFEBANDS WITH LOT #181831 ARE UNSECURED AND CAN EASILY COME OFF FROM THE ZOLL AUTOPULSE PLATFORMS (SN UNKNOWN). NO PATIENT INVOLVEMENT. RELATED MFR REPORT: MFR 3010617000-2024-00025 FOR THE AUTOPULSE PLATFORM #1. MFR 3010617000-2024-00021 FOR THE AUTOPULSE PLATFORM #2.

    Description of Event or Problem · 0

    DURING THE DEVICE CHECK, THE CUSTOMER REPORTED THAT THE LIFEBANDS WITH LOT #181831 ARE UNSECURED AND CAN EASILY COME OFF FROM THE ZOLL LOANER AUTOPULSE PLATFORMS (B)(6) NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674873 AUTOPULSE® LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION MODEL 100 181831 00849111001571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown