BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M300

    MDR report key: 2252963 · Received August 30, 2011

    Report

    Report Number
    1220063-2011-00042
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Report Date
    July 22, 2011
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATION THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE M300 DISPLAYED A "BED DISCONNECTED" MESSAGE AT THE ASSOCIATED ICS (INFINITY CENTRAL STATION). WHEN A NURSE RESPONDED TO THE PT ROOM, THE M300 WAS DISPLAYING A "DISCHARGE" MESSAGE AND APPEARED TO HAVE DISCHARGED THE PT WITHOUT USER INTERVENTION. THE HOSPITAL BIOMED EVALUATED THE UNITS AND REPORTED THAT AFTER READMITTING THE M300 TO THE ICS, THE DEVICE WAS RETURNED TO USE. WHEN DRAEGER INITIALLY RECEIVED THIS REPORT, IT WAS DETERMINED TO BE NOT REPORTABLE BECAUSE FOR AN M300 UNINTENDED BEDSIDE DISCHARGE, AN ALARM WILL GENERATE AT THE ICS TO ALERT THE CLINICIAN. HOWEVER, UPON FURTHER INVESTIGATION, THERE IS CONCERN ABOUT MISSING THE ALARM AT THE ICS. THEREFORE, IT WAS DETERMINED THAT THIS COMPLAINT IS REPORTABLE. DRAEGER REFERENCE NUMBER: 27055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M300 PATIENT MONITOR MHX DRAGER MEDICAL SYSTEMS, INC. MS22862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO