BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART RATE RESPIRATION MONITOR

    MDR report key: 531057 · Received March 2, 2004

    Report

    Report Number
    2244861-2004-00005
    Event Type
    Malfunction
    Date Received
    March 2, 2004
    Date of Event
    February 1, 2004
    Report Date
    March 2, 2004
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOME CARE DEALER REPORTS THAT THE MONITOR TURNS ITSELF ON AND OFF IN BETWEEN POWER UP AND POWER DOWN. THEY FURTHER CLAIM THAT THE MONITOR DID NOT ALARM WHEN IT SHOULD HAVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN