BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 18454613 · Received January 5, 2024

    Report

    Report Number
    3010617000-2024-00022
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Report Date
    March 8, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111001014
    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

    ZOLL HAS NOT RECEIVED THE AUTOPULSE PLATFORM (SN (B)(6) 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 PLATFORM'S (SN (B)(6) SLOTS AND CAN FALL OUT EASILY WITH A GENTLE TUG WAS CONFIRMED DURING THE TESTING AT ZOLL. THE REPORTED COMPLAINT'S ROOT CAUSE WAS THE OUT-OF-SPECIFICATION DIE-CAST CHANNEL. THE AUTOPULSE PLATFORM USED DURING THE REPORTED EVENT WAS MANUFACTURED IN 2011 AND HAS 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 ARCHIVE DATA INDICATED NO SIGNIFICANT DISCREPANCIES. DURING FUNCTIONAL TESTING, THE CAUSE FOR THE REPORTED COMPLAINT WAS IDENTIFIED AS AN OUT-OF-SPECIFICATION DIE-CAST CHANNEL. HOWEVER, IT DOES NOT AFFECT THE FUNCTIONALITY OF THE AUTOPULSE PLATFORM, AND IT PASSED THE FUNCTIONAL TESTING WITHOUT ERROR OR FAULT. A LOAD CELL CHARACTERIZATION TEST CONFIRMED THAT BOTH CELL MODULES FUNCTION WITHIN THE SPECIFICATION. FOLLOWING SERVICE, THE AUTOPULSE PLATFORM PASSED THE RUN-IN AND FINAL TESTS WITHOUT FAULT OR ERROR. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND NO SIMILAR COMPLAINT WAS REPORTED FOR THE AUTOPULSE PLATFORM WITH 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 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 3010617000-2024-00024 FOR THE AUTOPULSE PLATFORM SN (B)(6). MFR 3010617000-2023-01048 FOR THE LIFEBAND (LOT #181831).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949207 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111001014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown