BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON XL PATIENT MONITOR

    MDR report key: 19661 · Received February 13, 1995

    Report

    Report Number
    MW1005123
    Event Type
    Malfunction
    Date Received
    February 13, 1995
    Date of Event
    February 3, 1995
    Report Date
    February 6, 1995
    Manufacturer
    MENNEN MEDICAL, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EKG ALARM AUTOMATICALLY SHUT ITSELF OFF DESPITE THE ALARM NOTIFY SETTING BEING ON. NO ALARM SOUNDED TO SIGNIFY THAT THE ALARM AUTOMATICALLY SHUT OFF. THE MFR WAS NOTIFIED BUT NO ACTION WAS TAKEN. THIS PROBLEM HAS BEEN INTERMITTANT AND ONGOING FOR A FEW MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON XL PATIENT MONITOR PRECONFIGURED PATIENT MONITOR MHX MENNEN MEDICAL, INC. 277

    Patients

    Seq Age Sex Outcome Treatment
    1 *