BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 4130704 · Received September 30, 2014

    Report

    Report Number
    3010617000-2014-00487
    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 IT'S ORIGINAL PACKAGING. THE COMPRESSION PAD WAS RECEIVED DIRTY. FURTHER INSPECTION OF THE RETURNED UNIT REVEALED MULTIPLE CREASES AND TWISTS ON THE SURFACE OF THE BELT GUARD, INDICATING THAT THE UNIT WAS USED. THE RUB GUARD LINER THAT CONNECTS TO BOTTOM OF THE COMPRESSION PAD OF THE RIGHT BELT GUARD CAP, WAS COMPLETELY TORN APART AND RIPPED. IT APPEARED THAT THE UNIT HAD BEEN USED AND THE DAMAGE WAS DUE TO WEAR AND TEAR. FUNCTIONAL TESTING REVEALED THAT BOTH HINGED SKIRTS 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. SINCE THE CONDITION OF THE RETURNED UNIT WAS TORN AND RIPPED; ADDITIONAL FUNCTIONAL TESTING USING A TEST AUTOPULSE AND MANNEQUIN COULD NOT BE PERFORMED. VISUAL INSPECTION OF THE CLIPS REVEALED THAT BOTH THE HOOK AND HINGE PIN ON BOTH THE LEFT AND RIGHT SKIRTS HAD BEEN BENT OUT OF POSITION. BASED ON THE CONDITION OF THE UNIT, THE CAUSE OF THE LEFT AND RIGHT CLIPS 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 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
    608332 AUTOPULSE® LIFEBAND CHEST COMPRESSION ASSEMBLY DRM ZOLL CIRCULATION 8700-0706-01 47156

    Patients

    Seq Age Sex Outcome Treatment
    1