BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEALTHDYNE

    MDR report key: 17023 · Received March 22, 1994

    Report

    Report Number
    1024404-1994-00002
    Event Type
    Death
    Date Received
    March 22, 1994
    Date of Event
    February 26, 1994
    Report Date
    March 2, 1994
    Manufacturer
    HEALTHDYNE, INC.
    Product Code
    FLS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOTH PARENTS AND BABY WERE ASLEEP WHEN APNEA MONITOR ALARM FOR LOW HEART RATE SOUNDED. WHEN PARENTS CHECKED THE BABY WAS LIMP AND THE FATHER BEGAN CPR. THE BABY WAS TAKEN TO ONE HOSPITAL AND SUBSEQUENTLY TRANSFERRED TO ANOTHER WHERE DEATH WAS PRONOUNCED. PARENTS WERE CONCERNED THAT AN APNEA ALAAARM HAD NOT ALSO BEEN INDICATED. HOWEVER, THEY ARRIVED WITHIN TWENTY (20) SECONDS OF THE HEART RATE ALARM AND BEGAN CPR. THEREFORE THE APNEA ALARM HAD NOT YET BEEN ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTHDYNE APNEA MONITOR FLS HEALTHDYNE, INC. 900SL

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Death NONE KNOWN