BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVENT LINK 511 APNEA MONITOR

    MDR report key: 375147 · Received February 1, 2002

    Report

    Report Number
    2244861-2002-00006
    Event Type
    Malfunction
    Date Received
    February 1, 2002
    Date of Event
    December 1, 2001
    Report Date
    February 1, 2002
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEALER REPORTS THAT THE MONITOR AUDIBLE ALARM WILL NOT SOUND AT MONITOR START-UP OR WHILE MONITOR IS HOOKED UP TO A PT, WHICH IS WHEN IT WAS FOUND NOT TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVENT LINK 511 APNEA MONITOR BREATHING FREQUENCY MONITOR FLS CAS MEDICAL SYSTEMS, INC. 511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN