BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMI PLUS MONITOR

    MDR report key: 2541857 · Received April 4, 2012

    Report

    Report Number
    2244861-2012-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 6, 2012
    Report Date
    April 3, 2012
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    BZQ
    PMA / PMN Number
    K961972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE MONITOR WAS EVALUATED BY THE HOME CARE DEALER IT WAS RETURNED TO CAS WHERE IT WAS FURTHER RUN FOR OVER 1 WEEK ALL THE WHILE CHALLENGED WITH INPUT DATA DESIGNED TO CAUSE ALARM EVENTS. THE MONITOR WORKED AS IT SHOULD.

    Description of Event or Problem · 1

    AS REPORTED BY THE HOME CARE DEALER, THE PARENTS ENTERED THE BABY'S ROOM AND SAW THE ALARM LIGHTS ON AND SUBSEQUENTLY INFORMED THE APNEA PROGRAM PEOPLE THAT THE MONITOR DID NOT ALARM. THERE WAS NO IMPACT TO THE BABY REPORTED. THE MONITOR WAS GIVEN TO THE HOME CARE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMI PLUS MONITOR APNEA MONITOR BZQ CAS MEDICAL SYSTEMS, INC. 9700B

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO