BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 16397989 · Received February 17, 2023

    Report

    Report Number
    3010617000-2023-00172
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Report Date
    February 17, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111001571
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED AUTOPULSE LIFEBAND FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE PRODUCT IS RETURNED, AND INVESTIGATION HAS BEEN COMPLETED. DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    PATIENT 2 OF 2. THE AUTOPULSE PLATFORM (SN 33321) WAS USED TO RESUSCITATE A PATIENT IN CARDIAC ARREST. THE USER INSTALLED THE NEW LIFEBAND (LOT# UNKNOWN) BY SNAPPING IT TO THE PLATFORM WITH FOUR LOCKING TABS, HOWEVER, UPON LIFTING THE PLATFORM, THE LIFEBAND COVER PLATE WAS DETACHED FROM THE BACK OF THE DEVICE. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: FOR PATIENT 1 OF 2, AUTOPULSE PLATFORM (SN (B)(4)), SEE: MFR 3010617000-2023-001171 FOR PATIENT 2 OF 2, SEE: MFR 3010617000-2023-00166 FOR THE PLATFORM AND MFR 3010617000-2023-00168 FOR THE LIFEBAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116268 AUTOPULSE® LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION MODEL 100 UNKNOWN 00849111001571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown