BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 4200815 · Received October 24, 2014

    Report

    Report Number
    3010617000-2014-00548
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE LIFEBAND IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.PLEASE SEE THE FOLLOWING RELATED MFR. REPORTS: #3010617000-2014-00542 FOR AUTOPULSE® LIFEBAND #1 WITH SN: UNKNOWN, #3010617000-2014-00543 FOR AUTOPULSE® LIFEBAND #2 WITH SN: UNKNOWN, #3010617000-2014-00544 FOR AUTOPULSE® LIFEBAND #3 WITH SN: UNKNOWN, #3010617000-2014-00547 FOR AUTOPULSE® LIFEBAND #4 WITH SN: UNKNOWN, #3010617000-2014-00549 FOR AUTOPULSE® LIFEBAND #6 WITH SN: UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE LIFEBAND IN COMPLAINT WAS RETURNED TO ZOLL ON 11/03/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: THE LIFEBAND WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. IT WAS RECEIVED DIRTY WITH YELLOW STAINS ON THE COMPRESSION PAD. IT APPEARED TO HAVE BEEN USED. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED. FUNCTIONAL TESTING REVEALED THAT THE LEFT AND RIGHT HINGED SKIRTS OF THE COVER PLATE "SNAPPED" INTO THE RETRACTED POSITION. THE HOOK CAUGHT THE CAM STYLE TUMBLER SECURING THE "BUTTERFLY CLIP" TIGHTLY. IT SHOULD BE NOTED THAT NO ISSUES WERE ENCOUNTERED WHEN COMPRESSION TESTING WAS PERFORMED. A TEST AUTOPULSE PLATFORM RAN FOR 10 MINUTES USING THE RETURNED LIFEBAND AND A MANNEQUIN. THE UNIT PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CUSTOMER SITE VISIT, A ZOLL AUTOPULSE DEPLOYMENT SPECIALIST FOUND 6 DEFECTIVE AUTOPULSE LIFEBANDS. THE LIFEBANDS WERE FOUND TO HAVE "SKIRTS" (HINGED BELT GUARDS) THAT WERE IN THE CLOSED POSITION (FLIPPED DOWN) ON AT LEAST ONE SIDE AND NOT BOTH. WHEN THE BELT GUARDS WERE OPENED (FLIPPED UP), THERE WERE NO CLICKING SOUNDS AND THE "SKIRT" WOULD NOT HOLD IN THE "UP" POSITION. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679790 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION 8700-0706 47156

    Patients

    Seq Age Sex Outcome Treatment
    1