BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAS MEDICAL SYSTEMS, INC.

    MDR report key: 5508215 · Received January 18, 2005

    Report

    Report Number
    5508215
    Event Type
    Malfunction
    Date Received
    January 18, 2005
    Date of Event
    January 17, 2005
    Report Date
    January 18, 2005
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAS 511 COMBINATION MONITOR WAS FOUND BY CLINICIAN TO BE IN A MONITORING CONDITION WHERE ALL HEART AND RESPIRATORY RATE VALUES AND INDICATORS WERE FROZEN ON THE LED DISPLAY. DURING THIS EVENT THERE WAS NO INDICATION OF PT MONITORING, AND NO ALARM SOUNDED TO ALERT THE CLINICIAN. THE MONITOR WAS PLUGGED INTO A/C POWER AT THE TIME OF THE INCIDENT. NO HARM TO THE RESIDENT OCCURRED. THE MONITOR WAS IMMEDIATELY REMOVED FROM THE RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAS MEDICAL SYSTEMS, INC. COMBINATION MONITOR MWI CAS MEDICAL SYSTEMS, INC. 511

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other