BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETAL MONITOR

    MDR report key: 17541823 · Received August 11, 2023

    Report

    Report Number
    MW5144527
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    August 10, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS FOUND THAT THE FETAL HEART RATE MONITOR COULD NOT SCAN THE PATIENT'S UTERINE CONTRACTIONS, AND THE EQUIPMENT WAS SHUT DOWN FOR INSPECTION IMMEDIATELY AFTER THE FAILURE OCCURRED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707309 FETAL MONITOR FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FM20/M2702A DE55941879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown