BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 4995854 · Received August 12, 2015

    Report

    Report Number
    9610816-2015-00153
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    March 9, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT TO REPORT # 1218950-2015-01689. THE PRODUCT NUMBER WAS CHANGED FROM M4735A TO M8105A (865024) TO REFLECT THE INTELLIVUE MP5. THIS REPORT WAS CREATED TO REFLECT THE NEW FDA REGISTRATION NUMBER 9610816. CONTRACT OFFICE CORRECTION: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "HEARTSTART XL DEFIBRILLATOR/MONITOR/INTERRUPTED MACHINE". IT WAS ESTABLISHED THAT THIS WAS NOT AN ISSUE WITH THE HEARTSTART XL DEFIBRILLATOR, BUT THAT THE ECG WAVEFORM OF THE INTELLIVUE MP5 PATIENT MONITOR WAS DISTORTED DUE TO INTERFERENCE. NO DEATH OR PATIENT/USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529454 INTELLIVUE MP5 MHX MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1