BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLANKETROL

    MDR report key: 6212355 · Received December 29, 2016

    Report

    Report Number
    6212355
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    September 10, 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

    SMALL BLANKETROL WATER MATTRESS BEGAN LEAKING AFTER ATTACHED TO MACHINE, SHORTLY AFTER BEING TURNED ON.  LEAK WAS NOTICED IMMEDIATELY, PATIENT WAS NOT IN ROOM YET, SET UP WAS NOT CONTAMINATED.  MATTRESS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863111 BLANKETROL SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB- ZERO PRODUCTS, LLC NA 745270, (01) 1 0613031 82174

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR