BEUDAMED
    FDA Adverse Event Death Summary report: N

    AEQUITRON MEDICAL

    MDR report key: 36312 · Received August 23, 1996

    Report

    Report Number
    36312
    Event Type
    Death
    Date Received
    August 23, 1996
    Date of Event
    August 11, 1996
    Report Date
    August 22, 1996
    Manufacturer
    AEQUITRON MEDICAL, INC.
    Product Code
    FLS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT WAS ON APNEA MONITOR AT HOME. MONITOR WAS TURNED OFF ON 8/10/96 AT 11:58 P.M. AND INFANT EXPIRED ON 8/11/96 AT APPROX. 7:00 A.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEQUITRON MEDICAL RESPIRATION/HEART RATE MONITOR FLS AEQUITRON MEDICAL, INC. 9500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death