BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRIX, DOMESTIC

    MDR report key: 7060989 · Received November 27, 2017

    Report

    Report Number
    0001831750-2017-00536
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 30, 2017
    Report Date
    March 29, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INCLUDE UDI.

    Additional Manufacturer Narrative · 1

    DATA FROM THE DEVICE WAS REVIEWED AND IT WAS IDENTIFIED THAT THE PATIENT TEMPERATURE HAD DEVIATED MORE THAN A DEGREE FOR MORE THAN 30 MINUTES. IT WAS IDENTIFIED THAT THIS MAY HAVE BEEN ATTRIBUTED TO THE PROBE BEING DISCONNECTED AND THEN RECONNECTED AND THEN WHEN RECONNECTED IT MAY HAVE BEEN PLACED IN A POSITION WHERE IT WAS TOUCHING THE COOLING BLANKET WHICH CAUSED THE TEMPERATURE TO READ LOW. THIS FEEDBACK WAS PROVIDED TO THE USER FACILITY. THE USER FACILITY WAS NOT ABLE TO RECALL WHAT THE CODE WAS ON THE DEVICE WHEN THIS ISSUE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY THE USER HAS EXPERIENCED TEMPERATURE OVERSHOOT WHILE USING THE DEVICE. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY THE USER HAS EXPERIENCED TEMPERATURE OVERSHOOT WHILE USING THE DEVICE. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY THE USER HAS EXPERIENCED TEMPERATURE OVERSHOOT WHILE USING THE DEVICE. THE PATIENT WAS NOT AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840883 ALTRIX, DOMESTIC SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1