BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI THERM LITE BLANKET FOR BLANKETROL III

    MDR report key: 6906747 · Received October 2, 2017

    Report

    Report Number
    6906747
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    July 6, 2017
    Report Date
    September 8, 2017
    Manufacturer
    CINCINNATI SUB ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COOLING BLANKETS FOUND TO BE LEAKING WATER THROUGH THE BLANKET BUT NOT AT A SEAM. THERE WAS NO PATIENT HARM. MANUFACTURER RESPONSE: FOR COOLING BLANKET, MAXI THERM LITE BLANKET FOR BLANKETROL III (PER SITE REPORTER). THIS IS NOT A NEW ISSUE WITH THEIR PRODUCT AND WE HAVE REPORTED SIMILAR INCIDENCES PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687325 MAXI THERM LITE BLANKET FOR BLANKETROL III SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB ZERO PRODUCTS, INC. 873 57870-A

    Patients

    Seq Age Sex Outcome Treatment
    1