BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 4130635 · Received September 30, 2014

    Report

    Report Number
    3010617000-2014-00486
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 13, 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 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.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE LIFEBAND WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LIFEBAND WAS NOT RECEIVED IN IT'S 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 BELT WAS COMPLETELY TWISTED OUT OF POSITION. IT APPEARED THAT THE UNIT HAD BEEN USED AND THIS DAMAGE WAS DUE TO WEAR AND TEAR. FUNCTIONAL TESTING REVEALED THAT THE RIGHT HINGED SKIRT OF THE COVER PLATE WOULD NOT "SNAP" INTO THE RETRACTED POSITION. THE HOOK DID NOT CATCH THE CAM STYLE TUMBLER SECURING THE "BUTTERFLY CLIP" TIGHTLY. BOTH SKIRTS WOULD NOT SNAP INTO PLACE ALLOWING THE "BUTTERFLY" CLIP TO FALL OPEN, THUS CONFIRMING THE REPORTED COMPLAINT. WITH THE CONDITION OF THE UNIT BEING SEVERELY TWISTED, FUNCTIONAL TESTING WITH A TEST AUTOPULSE AND MANNEQUIN COULD NOT BE PERFORMED. VISUAL INSPECTION OF THE CLIPS REVEALED THAT BOTH THE HOOK AND HINGE PIN ON THE RIGHT SKIRT HAD BEEN BENT OUT OF POSITION. BASED ON THE CONDITION OF THE UNIT, THE CAUSE OF THE RIGHT CLIP NOT OPENING AND CLOSING PROPERLY HAS BEEN DETERMINED TO BE HANDLING DAMAGE SUSTAINED DURING USE OR STORAGE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE LIFEBAND WAS DEFECTIVE. CUSTOMER INDICATED THAT THE BLACK U SHAPED BELT GUARD CLIPS ON THE SIDES OF THE LIFEBAND DID NOT "CLICK" AND SNAP INTO PLACE ON THE METAL POST AT EITHER SIDE OF THE LIFEBAND. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608827 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION 8700-0706-01 47156

    Patients

    Seq Age Sex Outcome Treatment
    1