BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M3150 INFO CNTR LOCAL DATABASE REL N.0

    MDR report key: 3880792 · Received May 29, 2014

    Report

    Report Number
    1218950-2014-03003
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 CONTACTED PHILIPS TO REPORT THAT THE "TELEMETRY" WAS NOT WORKING. WE ARE CONSIDERING THIS ISSUE TO BE THAT THE ECG WAVEFORM COULD NOT BE ACQUIRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317147 M3150 INFO CNTR LOCAL DATABASE REL N.0 MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1