BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 2050123 · Received April 5, 2011

    Report

    Report Number
    1220063-2011-00012
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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. CORRECTION: THIS REPORT WAS INITIALLY, INADVERTENTLY SUBMITTED UNDER MFR REPORT # 1220063-2011-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOWER LIMIT OF HEART FREQUENCY WAS NOT RECOGNIZED. THE CLINICAL BIOMED DEPARTMENT CHECKED THE MOTOR USING TWO DIFFERENT SIMULATORS AND NO FAILURE WAS IDENTIFIED. THERE WAS NO PT INJURY REPORTED. (B)(4). CORRECTION: THIS REPORT WAS INADVERTENTLY SUBMITTED UNDER 1220063-2011-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS13464 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO