BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL

    MDR report key: 6212375 · Received December 29, 2016

    Report

    Report Number
    6212375
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    September 2, 2016
    Report Date
    November 22, 2016
    Manufacturer
    CINCINNATI SUB- ZERO PRODUCTS, LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLANKETROL PED BLANKET WITH LEAK UPON REMOVAL FROM PACKAGE.  BLANKET WAS REMOVED FROM PACKAGE AND HOOKED UP TO MACHINE AND WHEN FILLED WITH WATER IMMEDIATELY WATER SPRAYED FROM IT.  (WATER DID NOT REACH STERILE FIELD OR PATIENT.)  MACHINE IMMEDIATELY TURNED OFF AND BLANKET REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864394 BLANKETROL SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB- ZERO PRODUCTS, LLC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR