BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3823078 · Received April 30, 2014

    Report

    Report Number
    1218950-2014-02364
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORT THAT VTACH WAS NOT AUDIBLY ALARMING AT THE CENTRAL STATION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259513 NA NA MKJ PHILIPS MEDICAL SYSTEMS 862197

    Patients

    Seq Age Sex Outcome Treatment
    1