BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEALTHCARE MONITOR

    MDR report key: 9592144 · Received January 14, 2020

    Report

    Report Number
    MW5092238
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 24, 2019
    Report Date
    January 10, 2020
    Manufacturer
    PHILIPS HEALTHCARE / PHILIPS MEDIZIN SYSTEMS BOEBLINGEN GMBH
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PHILIPS M3001A A04 MMS UNABLE TO PROVIDE SPO2 VALUE, ESPECIALLY ON LOW-PERFUSION / COMPROMISED PTS. MALFUNCTION IS NOT LIMITED TO ONE DEVICE. MULTIPLE TROUBLESHOOTING HAS OCCURRED, AND ANTICIPATE A SOFTWARE / HARDWARE PROBLEM WITH THE A04 CONFIGURATION. PREVIOUS A02 CONFIGURATION DID NOT HAVE THE SAME MALFUNCTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52578 PHILIPS HEALTHCARE MONITOR MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS MWI PHILIPS HEALTHCARE / PHILIPS MEDIZIN SYSTEMS BOEBLINGEN GMBH INTELLIVUE MMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other