BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYP0 PAD

    MDR report key: 3000327 · Received March 12, 2013

    Report

    Report Number
    0001831750-2013-01959
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BLANKET COULD NOT CONFIRM THE ALLEGED LEAK EVENT REPORTED BY THE USER FACILITY. THE PAD WAS FILLED WITH WATER AND NO LEAKS COULD BE IDENTIFIED. HOWEVER IT WAS IDENTIFIED THAT THE HOSE CONNECTORS AND TUBING HAD BEEN CUT OFF BY THE CUSTOMER. IT IS POSSIBLE THAT THE LEAK MAY HAVE BEEN COMING FROM THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPOTHERMIA PAD WAS DAMAGED AND LEAKING FLUID. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPOTHERMIA PAD WAS DAMAGED AND LEAKING FLUID. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103391 HYP0 PAD SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1