BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE PERINATAL ADV SYS, INTEG ED

    MDR report key: 12195154 · Received July 20, 2021

    Report

    Report Number
    9610816-2021-10235
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 8, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K100420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM SYSTEM DOES NOT WORK WELL. THE DEVICE WAS IN USED FOR PATIENT MONITORING AT THE TIME OF THE ALLEGED MALFUNCTION. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095504 INTELLISPACE PERINATAL ADV SYS, INTEG ED INTELLISPACE PERINATAL ADV SYS, INTEG ED HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866132

    Patients

    Seq Age Sex Outcome Treatment
    1