BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE PERINATAL ADV SYS, INTEG ED

    MDR report key: 4679748 · Received April 10, 2015

    Report

    Report Number
    9610816-2015-00079
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Report Date
    March 28, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K100420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHE WAS LOSING THE SOUND CAPABILITY ON THE PC. NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AUDIBLE ALARMS FROM THEIR OBTV SYSTEM. THERE WAS NO PATIENT HARM REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241078 INTELLISPACE PERINATAL ADV SYS, INTEG ED PERINATAL MONTIORING SYSTEM HGM PHILIPS MEDICAL SYSTEMS 866132

    Patients

    Seq Age Sex Outcome Treatment
    1