BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMI PLUS MONITOR

    MDR report key: 2489370 · Received March 7, 2012

    Report

    Report Number
    2244861-2012-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 8, 2012
    Report Date
    March 7, 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

    Narratives

    Additional Manufacturer Narrative · 1

    CAS INTENDS TO TEST / RUN THIS DEVICE OVER AN EXTENDED PERIOD, WHICH AS OF TODAY, IS JUST 6 DAYS OF TESTING. THE MONITOR AFTER 2 DAYS IS OPERATING AND RESPONDING CORRECTLY. TESTING WILL CONTINUE WITH NEGATIVE RESULTS NOT EXPECTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE HOME CARE DEALER, THE DEVICE, USED FOR APNEA MONITORING, WAS ALLEGED TO NOT BE ALARMING WHEN THE MOTHER LOOKED IN ON THE BABY AND OBSERVED THE BABY TO HAVE A BLUE COLORATION. THE MOM THEN STARTLED THE BABY. IT WAS NOT STATED IF THE MOM'S REACTION CAUSED A RESTART OF THE BABY'S BREATHING. NO TRIP TO THE HOSP WAS NECESSARY. THE REPORT STATES THAT THE MONITOR HAD ALARMED FOR APNEA TWO PREVIOUS TIMES. THE DISTRIBUTOR REPORTS THAT THE MONITORS LED'S INDICATED THAT THE MONITOR WAS COUNTING HEART RATE AND RESPIRATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention