BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL III

    MDR report key: 1898369 · Received October 28, 2010

    Report

    Report Number
    1516825-2010-00013
    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
    PMA / PMN Number
    K101589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS PLUGGED INTO AN ISOLATED DEDICATED OUTLET ON DRAEGER PONTA SUPPLY BEAM SYSTEM. THE CSZ IS WORKING WITH THE FACILITY IN ORDER TO RESOLVE AND FURTHER EVALUATE THIS ISSUE. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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 CUSTOMER ALLEGED THE POWER IN THE HOSPITAL WARD WAS DISRUPTED DUE TO THE DEVICE TRIPPING THE BREAKER. THIS OCCURRED ON THREE OCCASIONS. THE FIRST TWO TIMES, THE BREAKER TRIPPED WHEN THE POWER SWITCH WAS TURNED ON, AND THE THIRD TIME WHEN THEY ATTEMPTED TO INCREASE THE TEMPERATURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLANKETROL III THERMAL REGULATING SYSTEM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 233

    Patients

    Seq Age Sex Outcome Treatment
    1