BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 4130669 · Received September 30, 2014

    Report

    Report Number
    3010617000-2014-00489
    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 ZOLL FOR ANALYSIS. THE LIFEBAND WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. THE COMPRESSION PAD WAS RECEIVED DIRTY WITH SOME UNKNOWN STAIN MARKS AT THE TOP AND BOTTOM PADS. FURTHER INSPECTION OF THE RETURNED UNIT REVEALED MULTIPLE CREASES AND TWISTS ON THE SURFACE OF THE BELT GUARD INDICATING THAT THE UNIT WAS USED. NO OTHER ISSUES WERE OBSERVED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. VISUAL INSPECTION OF THE CLIPS REVEALED THAT BOTH THE HOOK AND HINGE PIN ON THE RIGHT AND LEFT SKIRT ARE IN GOOD WORKING CONDITION. 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. IT SHOULD BE NOTED THAT WHEN COMPRESSION TESTING WAS PERFORMED WITH THE RETURNED LIFEBAND FOR 10 MINUTES USING A TEST AUTOPULSE PLATFORM AND MANNEQUIN, NO ISSUES WERE ENCOUNTERED. THE UNIT PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® LIFEBAND WAS DEFECTIVE. THE LIFEBAND TAB WAS BENT. 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. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607255 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION 8700-0701 12846

    Patients

    Seq Age Sex Outcome Treatment
    1