BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 2961556 · Received February 11, 2013

    Report

    Report Number
    1828100-2013-00099
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO MDR #1828100-2013-00098. THE FIELD SVC REP (FSR) FOUND THAT THE SPEED CONTROL RESISTOR R2 CONTACT WIPER WAS WORN AND WILL NOT ADJUST TO 35.

    Description of Event or Problem · 1

    THE FIELD SVC REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE WATER PUMP DOES NOT RUN IN "COOL #2" MODE. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59918 DUAL COOLER/HEATER COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1