BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR/OXIMETER - HOSPITAL

    MDR report key: 4231753 · Received October 14, 2014

    Report

    Report Number
    1218950-2014-06091
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 11, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NPF
    PMA / PMN Number
    K032403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE DEVICE ALARM IS NOT LOUD ENOUGH. THERE WAS NO REPORTED PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649999 SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR/OXIMETER - HOSPITAL NPF PHILIPS MEDICAL SYSTEMS 1030271

    Patients

    Seq Age Sex Outcome Treatment
    1