BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M300

    MDR report key: 3071032 · Received April 3, 2013

    Report

    Report Number
    1220063-2013-00011
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ON-LINE MODE, THE ACOUSTIC ALARM GETS NOTIFIED AT THE ICS. BUT THE ACOUSTIC ALARM AT THE M300 DOES NOT WORK IN THE OFFLINE MODE. THE ERROR OCCURRED DURING MAINTENANCE. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137470 M300 PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS25755 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO