BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LIFEBAND

    MDR report key: 2946153 · Received January 4, 2013

    Report

    Report Number
    3003793491-2012-00661
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 28, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED. NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT A CORRECTION WAS MADE TO DATE OF EVENT. IN ADDITION, "OTHER SERIOUS" SHOULD NOT HAVE BEEN CHECKED UNDER OUTCOMES ATTRIBUTED TO ADVERSE EVENT ON THE INITIAL REPORT. THE AUTOPULSE LIFEBAND IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION REVEALED THAT THE TWO CIRCULAR PROTRUSION PINS OF THE CCA LOCATOR MALE FEATURE HAD BROKEN OFF AND WERE FOUND STUCK IN THE CCA LOCATOR FEMALE FEATURE. THE BELT GUARD WAS ALSO CONFIRMED TO BE BROKEN. THE TYVEK MATERIAL OF THE LIFEBAND WAS NOTED TO BE FRAYED AND TORN. THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED BASED ON VISUAL INSPECTION OF THE RETURNED PRODUCT. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIFEBAND'S BELT GUARD AND ALIGNMENT TAB WERE BROKEN. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4889 AUTOPULSE LIFEBAND LIFEBAND DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other