BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTRA

    MDR report key: 2150414 · Received June 21, 2011

    Report

    Report Number
    2150414
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MAQUET, INC
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE HEATER COOLER DEVICE DID NOT CONTROL THE TEMPERATURE ACCORDING TO SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTRA MAQUET HEATER COOLER DTR MAQUET, INC HCU30 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *