BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEBAND® LOAD-DISTRIBUTING BAND

    MDR report key: 18271825 · Received December 5, 2023

    Report

    Report Number
    3010617000-2023-01048
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Report Date
    July 25, 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

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COMPLAINT THAT THE LOCKING TABS ON THE COVER PLATE OF THE LIFEBAND (LOT # 181831) DO NOT SNAP INTO THE AUTOPULSE PLATFORMS (SN (B)(6)) SLOTS AND CAN FALL OUT EASILY WITH A GENTLE TUG WAS NOT CONFIRMED DURING THE TESTING AT ZOLL. THE LIFEBAND FUNCTIONED AS INTENDED USING THE KNOW-GOOD AUTOPULSE PLATFORM. THE REPORTED COMPLAINT'S ROOT CAUSE WAS THE OUT-OF-SPECIFICATION DIE-CAST CHANNEL. THE AUTOPULSE PLATFORMS USED DURING THE REPORTED EVENT WERE MANUFACTURED IN 2011 AND 2012 AND HAVE AN OLD VERSION OF THE DIE-CAST CHANNEL WITH WIDE DIMENSIONS, WHEREAS THE LIFEBAND USED DURING THE EVENT WAS MANUFACTURED IN 2022 AND HAS A LIFEBAND COVER PLATE DIMENSION THAT FITS THE NEW VERSION OF THE DIE-CAST CHANNEL. THIS OUT-OF-SPECIFICATION ISSUE WAS LIMITED TO THE AUTOPULSE PLATFORMS PRODUCED YEARS AGO BETWEEN 2011 AND 2012 AND WAS CORRECTED WITH A DESIGN CHANGE. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS NOTED. THE LIFEBAND PASSED THE FUNCTIONAL TESTING WITH NO ISSUES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE LOCKING TABS ON THE COVER PLATE OF THE LIFEBANDS WITH LOT #181831 DO NOT SNAP INTO THE AUTOPULSE PLATFORM'S SLOTS AND CAN FALL OUT EASILY WITH A GENTLE TUG (THE SAME FORCE WHEN REPOSITIONING THE DEVICE). THE CUSTOMER HAD TO SECURE THE LIFEBAND TO THE AUTOPULSE PLATFORM USING ADHESIVE TAPE. THE CUSTOMER NOTED THE REPORTED PROBLEM WHILE USING THE LIFEBANDS WITH THE ZOLL LOANER AUTOPULSE PLATFORMS (SN (B)(6) AND (B)(6)). NO PATIENT INVOLVEMENT. ZOLL PERSONNEL VISITED THE CUSTOMER SITE AND TESTED THE LIFEBANDS WITH LOT #181831 WITH THE ZOLL LOANER AUTOPULSE PLATFORMS (SN (B)(6) AND (B)(6)), AND THE REPORTED ISSUE PERSISTED. THE LOANER AUTOPULSE PLATFORMS WERE TESTED WITH OTHER LIFEBANDS, AND THE ISSUE PERSISTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2024-00022 FOR THE AUTOPULSE PLATFORM (SN (B)(6)). MFR 3010617000-2024-00024 FOR THE AUTOPULSE PLATFORM (SN (B)(6)).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE LOCKING TABS ON THE COVER PLATE OF THE LIFEBANDS WITH LOT #181831 DO NOT SNAP INTO THE AUTOPULSE PLATFORM'S SLOTS AND CAN FALL OUT EASILY WITH A GENTLE TUG. THE CUSTOMER HAD TO SECURE THE LIFEBAND TO THE AUTOPULSE PLATFORM USING ADHESIVE TAPE. PER THE CUSTOMER, THE REPORTED PROBLEM WAS NOTED WHILE USING THE LIFEBANDS WITH AUTOPULSE PLATFORMS (SN (B)(6) AND (B)(6)). NO DEVICE MALFUNCTION WAS REPORTED ON THE AUTOPULSE PLATFORMS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123256 LIFEBAND® LOAD-DISTRIBUTING BAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION 100 181831 00849111001571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown