BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUSAT PULSE OXIMETER

    MDR report key: 1439519 · Received August 5, 2009

    Report

    Report Number
    9613557-2009-00005
    Event Type
    Death
    Date Received
    August 5, 2009
    Date of Event
    June 23, 2009
    Report Date
    August 5, 2009
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K040831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOME HEALTHCARE AGENCY REPORTED THAT THEY WERE INFORMED OF A DEATH OF AN INFANT. THE AGENCY HAS NOT BEEN ABLE TO OBTAIN ANY INFO CONCERNING THE DEATH. THERE HAS BEEN NO ALLEGATION OF EQUIPMENT MALFUNCTION. THE MOTHER OF THE PT WILL NOT RELEASE THE MONITOR FOR INVESTIGATION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUSAT PULSE OXIMETER OXIMETERS DPZ GE HEALTHCARE 6051-0000-193

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Death