BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNERCOOL RTX

    MDR report key: 4173498 · Received September 19, 2014

    Report

    Report Number
    4173498
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 9, 2014
    Report Date
    September 19, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH INNERCOOL THERAPY. DEVICE BECAME ACCIDENTALLY UNPLUGGED THIS AM, PLUGGED BACK IN IMMEDIATELY AND RESET. THEN DEVICE SEEMED TO HAVE A SMALL POWER SURGE, BUT DID NOT SHUT OFF. PATIENT WAS COOLING, AND AT APPROXIMATELY 1300 TEMP BEGAN TO GO UP TO 37.5 (HIGHEST); MD WAS PAGED, HE THEN CAME UP TO THE UNIT TO ASSESS THE DEVICE. HE WAS INFORMED OF THAT THE DEVICE SEEMED TO STOP COOLING AT SOME POINT, BUT WAS STILL RUNNING. HE THEN TURNED THE CONSOLE OFF AND RESTARTED IT AND IT HAS BEEN RUNNING FINE SINCE THEN. THERE WAS ONE MESSAGE WHEN HE WAS GOING THROUGH THE SCREENS BEFORE THE MACHINE WAS TURNED OFF THAT SAID "THERAPY COMPLETE" AT 1500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582869 INNERCOOL RTX SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING NCX PHILIPS MEDICAL SYSTEMS 23-05 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR