BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIPLUS

    MDR report key: 2492884 · Received March 8, 2012

    Report

    Report Number
    MW5024609
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 8, 2012
    Manufacturer
    CAS MEDICAL
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE FAMILY THE ALARMS ARE NOT AUDIBLY SOUNDING; THE DOWNLOAD VIA THE APNEA PROGRAM SHOWS THAT THERE HAVE BEEN ALARMS. THE MONITOR ALARMS WHEN IT STARTS UP AND DOES THE SELF CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIPLUS APNEA MONITOR BZQ CAS MEDICAL AMIPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Disability