BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 2772262 · Received October 2, 2012

    Report

    Report Number
    1828100-2012-01259
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWC
    PMA / PMN Number
    PREAMED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER WAS ABLE TO DETERMINE THE PROBABLE CAUSE WAS DEFECTIVE THERMOSTATS. REPLACEMENT PARTS WERE ORDERED BY THE CUSTOMER. THE DEFECTIVE CAN NOT BE RETURNED. IF ADD'L INFO 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

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE OF THE DEVICE AT THE USER FACILITY'S SERVICE CENTER, THE HEATER COOLER WOULD NOT HOLD TEMPERATURE. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1