BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 50IP-2 INTRAPARTUM FETAL MONITOR

    MDR report key: 14013738 · Received April 5, 2022

    Report

    Report Number
    9610816-2022-00174
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 7, 2022
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL 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 ALARMS NEED TO BE CHECKED AS THEY DO NOT WORK. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SERIES 50IP-2 INTRAPARTUM FETAL MONITOR ALARMS NEED TO BE CHECKED AS THEY DO NOT WORK. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042919 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