BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 654848 · Received December 19, 2005

    Report

    Report Number
    2244862-2005-00014
    Event Type
    Death
    Date Received
    December 19, 2005
    Date of Event
    August 1, 2005
    Report Date
    December 19, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    BZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOME HEALTH CARE PROVIDER REPORTED THAT THE PATIENT HAD DIED. THE MONITOR WAS REPORTED TO WORK CORRECTLY AND WITHOUT COMPLAINT. A REPORT WAS MADE INDICATING NUMEROUS BRADYCARDIA AND APNEA EPISODES ALL VALIDATED. REPORT ALSO STATED THAT THE FAMILY DEMONSTRATED EXTREMELY POOR MONITORING COMPLIANCE, LOGGING 108 DAYS OF NON-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART RATE RESPIRATION MONITOR BREATING FREQUENCY MONITOR BZQ CAS MEDICAL SYSTEMS, INC. 9700B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death