BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 50A ANTEPARTUM FETAL MONITOR

    MDR report key: 16993020 · Received May 24, 2023

    Report

    Report Number
    9610816-2023-00248
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    September 20, 2022
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER AND ADVISED THAT THE SERIE 50 IS END OF LIFE SINCE 2013 AND THAT PHILIPS DOES NOT HAVE ANY PIECES ON THESE DEVICES ANYMORE. THE DEVICE WAS NO LONGER SUPPORTED AND ADVISED CUSTOMER TO BUY A NEW DEVICE FOR REPLACEMENT. THE DEVICE HAS REACHED THE END OF LIFE.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. E1: REPORTING INSTITUTION PHONE # (B)(6) E1: REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE HAS NO SOUND ANYMORE. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648879 SERIES 50A ANTEPARTUM FETAL MONITOR SERIES 50A ANTEPARTUM FETAL MONITOR HFM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 862336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown