BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LIFEBAND

    MDR report key: 2953861 · Received January 11, 2013

    Report

    Report Number
    3003793491-2013-00095
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIFEBAND BECAME UNHOOKED FROM THE PLATFORM DURING DEPLOYMENT. CUSTOMER ALSO TESTED LIFEBAND SN (B)(4), IT FELT LOOSE WHEN IN PLATFORM'S LIFEBAND HOUSING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17161 AUTOPULSE LIFEBAND LIFEBAND DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other