BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTV CLIENT

    MDR report key: 3761109 · Received December 31, 2013

    Report

    Report Number
    9610816-2013-00291
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Report Date
    December 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K970456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARMING IS NOT WORKING PROPERLY IN 2 ROOMS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682640 OBTV CLIENT HGM PHILIPS MEDICAL SYSTEMS M1382E

    Patients

    Seq Age Sex Outcome Treatment
    1