BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEBAND® LOAD-DISTRIBUTING BAND

    MDR report key: 21748818 · Received April 1, 2025

    Report

    Report Number
    3010617000-2025-00228
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 6, 2025
    Report Date
    May 7, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    UDI-DI
    10849111002988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN B5 (DESCRIBE EVENT OR PROBLEM), AND CODE UPDATE IN H6 (HEALTH EFFECT - CLINICAL CODE AND IMPACT CODE).

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. THE AUTOPULSE NXT BAND IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE THE CUSTOMER HAS DISPOSED OF IT. THEREFORE, PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING PATIENT RESUSCITATION WITH THE AUTOPULSE NXT PLATFORM, THE CREW OBSERVED A PROBLEM WITH AN NXT BAND (LOT #200888) THAT TWISTS INTERNALLY WITHIN THE DEVICE EVEN WHEN CORRECTLY ALIGNED ON THE PATIENT. THE FAILURE OCCURRED APPROXIMATELY 4 TO 5 MINUTES INTO OPERATION. A NOTICEABLE CHANGE IN THE SOUND OF THE AUTOPULSE MOTOR WAS NOTED, INDICATING THAT THE DEVICE WAS STRUGGLING AND BECOMING BOGGED DOWN. SHORTLY AFTER, IT STOPPED COMPRESSING. UPON ATTEMPTING A RESET, ONE SIDE OF THE BAND WAS DIFFICULT TO RETRACT, REVEALING THAT IT HAD BECOME BUNDLED WITHIN THE DEVICE. ADDITIONALLY, THE OUTER SLEEVE OF THE BAND APPEARED TO BE PULLED INTO ITSELF. AFTER RESETTING, THE BAND QUICKLY BECAME TANGLED AGAIN DUE TO THE CREASES AND FOLDS THAT HAD FORMED. ACCORDING TO THE CUSTOMER, THE PATIENT WAS OF AVERAGE SIZE. THE CREW REVERTED TO MANUAL CPR. NO PATIENT INJURIES WERE REPORTED.

    Description of Event or Problem · 0

    DURING PATIENT RESUSCITATION WITH THE AUTOPULSE NXT PLATFORM, THE CREW OBSERVED A PROBLEM WITH AN NXT BAND (LOT # 200888) THAT TWISTS INTERNALLY WITHIN THE DEVICE EVEN WHEN CORRECTLY ALIGNED ON THE PATIENT. THE FAILURE OCCURRED APPROXIMATELY 4 TO 5 MINUTES INTO OPERATION. A NOTICEABLE CHANGE IN THE SOUND OF THE AUTOPULSE MOTOR WAS NOTED, INDICATING THAT THE DEVICE WAS STRUGGLING AND BECOMING BOGGED DOWN. SHORTLY AFTER, IT STOPPED COMPRESSING. UPON ATTEMPTING A RESET, ONE SIDE OF THE BAND WAS DIFFICULT TO RETRACT, REVEALING THAT IT HAD BECOME BUNDLED WITHIN THE DEVICE. ADDITIONALLY, THE OUTER SLEEVE OF THE BAND APPEARED TO BE PULLED INTO ITSELF. AFTER RESETTING, THE BAND QUICKLY BECAME TANGLED AGAIN DUE TO THE CREASES AND FOLDS THAT HAD FORMED. ACCORDING TO THE CUSTOMER, THE PATIENT WAS OF AVERAGE SIZE. NO FURTHER INFORMATION WAS PROVIDED. THE 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
    2613888 LIFEBAND® LOAD-DISTRIBUTING BAND CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200 200888 10849111002988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown