BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL II

    MDR report key: 1898368 · Received October 28, 2010

    Report

    Report Number
    1516825-2010-00012
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS NOT RETURNING THE UNIT. ENGINEERING HAS EVALUATED THE INFO AND NO CONCLUSIONS CAN BE DRAWN. IN ORDER TO FURTHER INVESTIGATE, CSZ HAS REQUESTED ADDITIONAL INFO TO IDENTIFY ROOT CAUSE OF THE PROBLEM. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO FDA AS SOON AS NEW INFO OR INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE DISTRIBUTOR ALLEGED, "IN THE HEATING MODE WHEN WE SET TEMP TO 37C, HI-LIMIT ALARM ACTIVATES WHEN SYSTEM REACHES TO 33C AND MACHINE SHUTS OFF. WHEN AFTER SOME TIME, RESTART THE MACHINE WITH THE SAME TEMP I.E 37C. REACHING 37C, MACHINE CHANGES ITS MODE TO COOLING, BUT TEMP RISES TO 42C. AT THIS TIME, THE MACHINE IS DISPLAYING THE COOLING MODE BUT IS WORKING IN THE HEATING MODE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLANKETROL II THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 222R

    Patients

    Seq Age Sex Outcome Treatment
    1