BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETAL MONITOR

    MDR report key: 3823476 · Received May 1, 2014

    Report

    Report Number
    9610816-2014-00111
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    K921957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 REPORTED THAT "IT DOES NOT TRACE THE RIGHT VARIABILITY". NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261923 FETAL MONITOR HFM PHILIPS MEDICAL SYSTEMS M1351A

    Patients

    Seq Age Sex Outcome Treatment
    1