BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6126263 · Received November 23, 2016

    Report

    Report Number
    3010617000-2016-00843
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    July 29, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE,A PHYSICAL INVESTIGATION OF THE DEVICE WILL NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 11/01/2016, ZOLL RECEIVED A MEDWATCH REPORT (MW5064322) FROM THE FDA WHICH REPORTED THAT "THE FLUID FAILED TO CIRCULATE PROPERLY". MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, THE CUSTOMER HAD NO RECOLLECTION OF THE EVENT. NO OTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775362 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1