BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE PERINATAL ADV SYS, INTEG ED

    MDR report key: 5096842 · Received September 23, 2015

    Report

    Report Number
    9610816-2015-00206
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Report Date
    August 7, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K100420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARMS DON'T SOUND ON A WEB CLIENT. THE DEVICE WAS USED FOR PATIENT MONITORING. THERE IS NO REPORT OF AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARMS DON'T SOUND ON A WEB CLIENT. THERE IS NO REPORT OF A NEGATIVE USER/PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630114 INTELLISPACE PERINATAL ADV SYS, INTEG ED PERINATAL MONTIORING SYSTEM HGM PHILIPS MEDICAL SYSTEMS 866133

    Patients

    Seq Age Sex Outcome Treatment
    1