BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS INTELLIVUE MP5 PATIENT MONITOR

    MDR report key: 8908274 · Received August 19, 2019

    Report

    Report Number
    3007409280-2019-00005
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 25, 2019
    Report Date
    July 29, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    MHX
    PMA / PMN Number
    K082633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND IDENTIFIED THAT THE MP5 TAG WAS MISSING. TECHNICAL EVALUATION WAS PERFORMED WHICH CONFIRMED THE REPORTED ISSUE OF THERE BEING NO POWER ON THE RECORDER. THE TECHNICIAN REPLACED THE RECORDER BOARD WITH A REFURBISHED ONE, CHECKED FOR CASE DAMAGE, INSPECTED THE CIRCUIT BOARD, CHECKED THAT THE OPTIONS WERE SET TO H10 A04 C00 C01 C15 C20, SET THE SOFT TO M.04.00, AND TESTED THE DEVICE ON A SIMULATOR. THE DISPLAY TEST, ECG TEST, NETWORK LAN/WLAN CHECK, NIBP TEST, ON/OFF POWER TEST, RECORDER TEST, TEMPERATURE TEST, AND FINAL VISUAL INSPECTION ALL PASSED. BASED ON THE REPORTED EVENT AND THE DEVICE EVALUATION ANALYSIS THE ROOT CAUSE WAS DETERMINED TO BE A RECORDER BOARD FAILURE DUE TO AGED PARTS. NO FURTHER INVESTIGATION IS REQUIRED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST PURCHASE, THERE WAS NO POWER TO THE RECORDER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702299 PHILIPS INTELLIVUE MP5 PATIENT MONITOR MONITOR MHX PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1