BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 2860771 · Received December 5, 2012

    Report

    Report Number
    1828100-2012-01566
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWC
    PMA / PMN Number
    K071521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE (FSR). THE FSR REPLACED THE RESISTANCE TEMPERATURE DETECTOR (RTD) CABLE ASSEMBLY, THE DUAL THERMISTOR, THE D/C BOARD ON CHANNEL A, ALONG WITH A LONGER CIRCULATING LOOP. WITH THE PARTS REPLACED, THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THAT AN "EO4" ERROR MESSAGE OCCURRED ON CHANNEL A. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HX2 TEMPERATURE MANAGEMENT SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEM CORP 809810

    Patients

    Seq Age Sex Outcome Treatment
    1