BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUSAT

    MDR report key: 6845266 · Received September 6, 2017

    Report

    Report Number
    3008729547-2017-00010
    Event Type
    Death
    Date Received
    September 6, 2017
    Date of Event
    November 30, 2015
    Report Date
    November 1, 2017
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    DPZ
    PMA / PMN Number
    K040831
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION SUMMARY: THE TRUSAT WAS EVALUATED AND TESTED IN THE PRESENCE OF GEHC, PATIENT AND CUSTOMER (PREFERRED HOMECARE/LIFECARE SOLUTIONS) REPRESENTATIVES WHERE IT WAS INITIALLY NOTED THAT THE DEVICE WAS PROVIDING A FAULT CODE FOR A NON-OPERATIONAL SENSOR. IT WAS ALSO NOTED THAT THE DEVICE STILL CONTAINED HISTORICAL DATA WHICH INDICATED THAT THE TRUSAT ALARMED FOR LOW SPO2 AT THE OF THE EVENT (MEANING THE SENSOR WAS CLEARLY OPERATIONAL WHEN THE EVENT OCCURRED). FURTHERMORE, THE TRUSAT WAS TESTED FOR ALARM FUNCTIONALITY WITH A NEW (OPERATIONAL) SENSOR AND WAS FOUND TO BE ALARMING APPROPRIATELY. IT WAS OBSERVED DURING TESTING THAT THE VOLUME WAS SET ON IT VERY LOWEST SETTING ALTHOUGH IT CANNOT BE CONFIRMED TO WHAT SETTING THE VOLUME WAS CONFIGURED DURING THE TIME OF THE EVENT. THE INVESTIGATION FOR THIS EVENT CONCLUDED THERE WAS NO MALFUNCTION OF THE TRUSAT DEVICE. THE TRUSAT COMPLIES WITH (B)(4) SAFETY STANDARDS FOR ALARMS AND (B)(4) SAFETY STANDARDS WITH RESPECT TO VOLUME SETTINGS.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    GE HEALTHCARE RECEIVED INFORMATION FROM AN ATTORNEY ALLEGING THAT WHILE BEING USED IN A HOME ENVIRONMENT, THE TRUSAT MALFUNCTIONED IN SOME WAY IN THAT IT DID NOT ALARM WHEN THE PATIENT STOPPED BREATHING OR IT INDICATED THE PATIENT HAD A PULSE RATE AND WAS BREATHING WHEN HE WAS NOT. THE PATIENT SUBSEQUENTLY EXPIRED. GE HEALTHCARE¿S INVESTIGATION IS ONGOING, TO ATTEMPT TO DETERMINE THE PRECISE ALLEGED MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625749 TRUSAT OXIMETER, EAR DPZ CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death