BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 4200756 · Received October 24, 2014

    Report

    Report Number
    3010617000-2014-00544
    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, #3010617000-2014-00547 FOR AUTOPULSE® LIFEBAND #4 WITH SN: UNKNOWN, #3010617000-2014-00548 FOR AUTOPULSE® LIFEBAND #5 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. NO DIRT OR SIGN OF USAGE WAS NOTED. THE UNIT APPEARED NEW AND HAD NOT BEEN USED. THE LEFT AND RIGHT SKIRT WOULD NOT SNAP INTO PLACE ALLOWING THE "BUTTERFLY" CLIP TO FALL OPEN INTO THE SIDE SLOT OF THE AUTOPULSE PLATFORM, THUS CONFIRMING THE REPORTED COMPLAINT. HOWEVER, 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 LIFEBAND STAYED IN PLACE DURING COMPRESSION TESTING WITH NO USER ADVISORIES OR OTHER ISSUES OBSERVED. IT SHOULD BE NOTED THAT DURING THE ONSITE CUSTOMER VISIT, THE LIFEBAND ASSOCIATED WITH THIS COMPLAINT WAS FOUND TO HAVE BEEN STORED IN AN UNSECURED BLUE STORAGE BAG, WHICH WAS KEPT IN THE CUSTOMER'S VEHICLE TRUNK. THERE WERE NO DIVIDERS IN THE TRUNK TO KEEP THE BAGS FROM MOVING AROUND. THE LIFEBAND HAD SKIRTS THAT WERE FOUND TO NOT CLICK NOR HOLD IN THE RETRACTED POSITION. BASED ON THE FULL INVESTIGATION, INCLUDING BOTH A PHYSICAL EVALUATION OF THE RETURNED LIFEBAND AS WELL AS THE OBSERVATIONS MADE DURING THE ONSITE CUSTOMER VISIT, THE CAUSE OF THE REPORTED COMPLAINT HAS BEEN DETERMINED TO BE HANDLING AND STORAGE OF THE LIFEBANDS AT THE CUSTOMER SITE.

    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
    679943 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION 8700-0706 47156

    Patients

    Seq Age Sex Outcome Treatment
    1