BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 50IP-2 INTRAPARTUM FETAL MONITOR

    MDR report key: 14341608 · Received May 9, 2022

    Report

    Report Number
    9610816-2022-00218
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 21, 2022
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SERIES 50IP-2 INTRAPARTUM FETAL MONITOR HAD AUDIO ISSUES (CANNOT BE HEARD WELL). IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME EVENT. NO ADVERSE EVENT TO THE PATIENT/USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SERIES 50IP-2 INTRAPARTUM FETAL MONITOR HAD AUDIO ISSUES (CANNOT BE HEARD WELL). IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME EVENT. NO ADVERSE EVENT TO THE PATIENT/USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632585 SERIES 50IP-2 INTRAPARTUM FETAL MONITOR SERIES 50IP-2 INTRAPARTUM FETAL MONITOR HFM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 862337

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown