BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRIX, DOMESTIC

    MDR report key: 6973128 · Received October 24, 2017

    Report

    Report Number
    0001831750-2017-00470
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 25, 2017
    Report Date
    March 29, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    DWJ
    PMA / PMN Number
    K152266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INCLUDE UDI.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHILE USING THE DEVICE, THE PATIENT EXPERIENCED TEMPERATURE DEVIATION. THE DEVICE WAS USED FOR HYPOTHERMIC COOLING AND THE MACHINE OVERSHOT THE TEMPERATURE AND WOULD NOT KEEP A CONSISTENT TEMPERATURE. IT WAS IDENTIFIED THAT THERE WERE NO ADVERSE CONSEQUENCES REPORTED TO THE PATIENT DURING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT WHILE USING THE DEVICE, THE PATIENT EXPERIENCED TEMPERATURE DEVIATION. THE DEVICE WAS USED FOR HYPOTHERMIC COOLING AND THE MACHINE OVERSHOT THE TEMPERATURE AND WOULD NOT KEEP A CONSISTENT TEMPERATURE. IT WAS IDENTIFIED THAT THERE WERE NO ADVERSE CONSEQUENCES REPORTED TO THE PATIENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750458 ALTRIX, DOMESTIC SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1