BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMAIR

    MDR report key: 1898421 · Received October 28, 2010

    Report

    Report Number
    1516825-2010-00011
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K101148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFO HAS BEEN OBTAINED AT THIS TIME. THE CUSTOMER HAS INDICATED THEY ARE SENDING THE UNIT BACK FOR EVAL. A F/U REPORT WILL BE SUBMITTED AFTER CSZ HAS EVALUATED THE UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED, THE UNIT'S ERROR CODE (AMBER WRENCH) IS ILLUMINATED AND THE UNIT HAS A BURNING SMELL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMAIR THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 135

    Patients

    Seq Age Sex Outcome Treatment
    1