BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEBAND® LOAD-DISTRIBUTING BAND

    MDR report key: 23006419 · Received September 9, 2025

    Report

    Report Number
    3010617000-2025-00647
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    UDI-DI
    00849111002981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. ZOLL HAS NOT RECEIVED THE AUTOPULSE NXT BAND IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE AUTOPULSE NXT BAND (LOT UNKNOWN) SNAPPED RIGHT ABOVE THE PIN DURING USE. THE CREW REPLACED THE BAND AND WHEN DOING SO, THEY NOTICED THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) WAS VERY HOT. THEN SHORTLY AFTER, THE PLATFORM THREW A CODE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836200 LIFEBAND® LOAD-DISTRIBUTING BAND CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC MODEL 200 UNKNOWN 00849111002981

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown