BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUSAT PULSE OXIMETER

    MDR report key: 1999253 · Received February 17, 2011

    Report

    Report Number
    2124823-2011-00014
    Event Type
    Death
    Date Received
    February 17, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 17, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K040831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO WAS USING A TRUSAT PULSE OXIMETER IN A HOME ENVIRONMENT DIED IN HER SLEEP. THE PT'S MOTHER REPORTED THAT SHE REC'D AN URGENT MEDICAL DEVICE CORRECTION LETTER FOR THE TRUSAT SEVERAL DAYS AFTER HER DAUGHTER'S DEATH. THE PT HAD BEEN DIAGNOSED WITH RETT SYNDROME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUSAT PULSE OXIMETER OXIMETER DPZ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death