BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 4130652 · Received September 30, 2014

    Report

    Report Number
    3010617000-2014-00488
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 5, 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 RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE LIFEBAND WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LIFEBAND WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. THE COMPRESSION PAD WAS RECEIVED DIRTY. FURTHER INSPECTION OF THE RETURNED UNIT REVEALED MULTIPLE CREASES ON THE SURFACE OF THE BELT GUARD INDICATING THAT THE UNIT WAS USED. THE RIGHT BELT THAT WAS CONNECTED TO THE BOTTOM OF THE COMPRESSION PAD, WAS SEVERELY TWISTED AND JAMMED WITH THE CLIP, TO THE EXTENT THAT IT FOLDED OVER THE BELT AND RIPPED. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON VISUAL INSPECTION. FROM THE CONDITION OF THE RETURNED UNIT, THE CAUSE HAS BEEN DETERMINED TO BE DAMAGE DUE TO HANDLING. FUNCTIONAL TESTING REVEALED THAT BOTH HINGED SKIRTS OF THE COVER PLATE "SNAPPED" INTO THE RETRACTED POSITION. THE HOOK CAUGHT THE CAM STYLE TUMBLER SECURING THE "BUTTERFLY CLIP" TIGHTLY. SINCE THE CONDITION OF THE UNIT WAS SEVERELY DAMAGED AND THE BELT WAS JAMMED, ADDITIONAL FUNCTIONAL TESTING WITH A TEST AUTOPULSE AND MANNEQUIN COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING TESTING ON A MANNEQUIN, IT WAS OBSERVED THAT THE AUTOPULSE® LIFEBAND WAS DEFECTIVE. THE LIFEBAND STRAP WAS TWISTED AND THE CLIP WAS CRACKED. CUSTOMER INDICATED THAT THE BELT GUARDS (BLACK U-SHAPED PLASTIC CLIPS) ON THE SIDES OF THE LIFEBAND DID NOT "CLICK" AND SNAP INTO PLACE ON THE METAL POST AT EITHER SIDE OF THE LIFEBAND. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607763 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION 8700-0706-01 47156

    Patients

    Seq Age Sex Outcome Treatment
    1