BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE PERINATAL ADV SYS, INTEG ED

    MDR report key: 10815766 · Received November 10, 2020

    Report

    Report Number
    9610816-2020-00412
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Report Date
    October 27, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K100420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DOES NOT SHOW ALARMS IN THE TELEMETRY. 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
    1281939 INTELLISPACE PERINATAL ADV SYS, INTEG ED PERINATAL MONTIORING SYSTEM HGM PHILIPS MEDICAL SYSTEMS 866132

    Patients

    Seq Age Sex Outcome Treatment
    1