BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 50IP-2 INTRAPARTUM FETAL MONITOR

    MDR report key: 12167944 · Received July 14, 2021

    Report

    Report Number
    9610816-2021-10223
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 30, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT THE ALARM OF THE FETAL MONITOR HAS ALARMED INSIDE THE ROOM, BUT THE ALARM HAS NOT ALARMED IN THE PERINATAL CENTRAL. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE ALARM OF THE FETAL MONITOR HAS ALARMED INSIDE THE ROOM, BUT THE ALARM HAS NOT ALARMED IN THE PERINATAL CENTRAL. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067583 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