BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3030724 · Received March 27, 2013

    Report

    Report Number
    1828100-2013-00304
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED IS PLANNING ON REPLACING THE OVER-TEMP THERMOSTAT.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE OVER-TEMP 43+ DEGREE THERMOSTAT DID NOT WORK PROPERLY, AS THE COOLER HEATER UNIT WENT TO 46+ DEGREES WHEN TESTING. THE OVER-TEMP LIGHT DID NOT COME ON EITHER. SINCE THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126175 DUAL COOLER/HEATER COOLING & HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1