BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 18896190 · Received March 13, 2024

    Report

    Report Number
    3010617000-2024-00257
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 26, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    10849111002247
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED DURING A VISUAL INSPECTION OF THE RETURNED AUTOPULSE LIFEBAND. THE LIFEBAND BAND CLIP (BELT CLIP) AND ONE OF THE TABS OF THE HINGED BELT GUARDS (SKIRTS) WERE NOTED TO BE BROKEN. THESE ISSUES PREVENTED THE PLACEMENT OF THE BAND CLIP INTO THE AUTOPULSE PLATFORM'S DRIVESHAFT AND PREVENTED THE LIFEBAND HINGED BELT GUARD FROM BEING SNAPPED IN PLACE, CONFIRMING THE REPORTED COMPLAINT. THE OBSERVED DAMAGE APPEARED TO BE AN ISOLATED INSTANCE OF EXCESSIVE FORCE APPLIED TO THE LIFEBAND BELT CLIP AND HINGED BELT GUARD DURING THE PLACEMENT OF THE LIFEBAND. DURING FURTHER INSPECTION, THE BROKEN BELT CLIP WAS REMOVED FROM THE BELT AND THE COMBINED LENGTH OF THE TWO PIECES MATCHED THE DIMENSIONS OF A KNOWN-GOOD LIFEBAND BELT CLIP. NO ADDITIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE LIFEBAND UPON RECEIPT. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR LIFEBAND WITH LOT #190702.

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE LIFEBAND IN 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

    DURING CHECKING LIFEBANDS BEFORE TREATMENT, THE CUSTOMER FOUND THE BAND CLIP AND HINGED BELT GUARD OF THE TWO NEWLY RECEIVED LIFEBANDS (LOT#190702) WERE BROKEN. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956417 AUTOPULSE® LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION MODEL 100 10849111002247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown