BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRWAY PRESSURE MONITOR WITH ALARM

    MDR report key: 23464 · Received December 9, 1994

    Report

    Report Number
    36222-1994-09001
    Event Type
    Death
    Date Received
    December 9, 1994
    Date of Event
    October 17, 1994
    Report Date
    October 26, 1994
    Manufacturer
    RESPIRONICS
    Product Code
    CAP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MOTHER RETURNED MY CALL (I HAD BEEN UNABLE TO REACH FAMILY FOR MANY DAYS) ON 10/18/94 AND TOLD ME THAT THE PT HAD DIED LAST NIGHT (10/17/94) IN THE HOSPITAL. SHE SAID SHE COULDN'T TELL ME WHAT HAD HAPPEN BUT THAT IT STARTED AT HOME AND WHEN THEY GOT TO THE HOSPITAL THE T WAS CLINICALLY BRAIN DEAD. SHE SAID THEERE WAS GOING TO BE AN INVESTIGATION & WANTED OUR EQUIPMENT LEFT AT HOME. SHE ALSO SAID IT WAS NOT OUR FAULT OR THE EQUIPMENT'S FAULT & NOT TO WORRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY PRESSURE MONITOR WITH ALARM AIRWAY PRESSURE MONITOR CAP RESPIRONICS 302220 OEM MONAHAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Death