BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMAIR

    MDR report key: 1884638 · Received October 24, 2010

    Report

    Report Number
    1516825-2010-00014
    Event Type
    Malfunction
    Date Received
    October 24, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K942790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER INFO HAS BEEN OBTAINED AT THIS TIME. THE UNIT WAS RETURNED TO CSZ FOR EVALUATION ON (B)(4) 2010. A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE UNIT CAUGHT FIRE AS IT WAS BEING WARMED UP PRIOR TO USE ON A PT . (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMAIR THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 134 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA