BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 7734066 · Received July 31, 2018

    Report

    Report Number
    3010617000-2018-00738
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    June 14, 2018
    Report Date
    July 30, 2018
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASAHI KASEI ZOLL MEDICAL (AZM) REPRESENTATIVE VISITED THE SITE AND CONFIRMED THE PROBLEM, AND ALSO CONFIRMED THAT THE CONSOLE COULD WORK NORMALLY AFTER RECONNECTING HMIA. AT THE TIME, AZM CONSIDERED THAT THE PROBLEM WOULD BE CAUSED BY DEPLETION OF INTERNAL-BATTERY IN THE MONITOR HEAD. HOWEVER, AZM-TECHNICAL SERVICE VISITED THE SITE LATER AND CHECKED THE CONSOLE, AND FOUND THAT THE PROBLEM REPRODUCED EVEN AFTER THE INTERNAL-BATTERY WAS REPLACED. AZM-TS CHECKED THE INSIDE OF CONSOLE, AND FOUND THAT LEDS AROUND THE I/O BOARD DID NOT LIT, TO REMEDY THE ISSUE TH I/O BOARD WILL BE REPLACED. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR THERMOGARD CONSOLE SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, DURING ROUTINE CHECK, THE CUSTOMER OBSERVED THAT THE THERMOGARD XP IVTM SYSTEM ((B)(4)) WAS ALARMING WITH BLACK SCREEN UPON POWERING ON. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578203 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1