BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 2121203 · Received May 4, 2011

    Report

    Report Number
    9610816-2011-00228
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    September 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THERE WAS A LOSS OF AUDIO AFTER RECEIVING A VISUAL "SPEAKER MALF." INOP. NO PT HARM WAS REPORTED. BOTH THE MAINBOARD AND SPEAKER WERE REPLACED TO RESOLVE THE AUDIO PROBLEM AND INOP. THE DEVICE LABELING (IFU) ADEQUATELY WARNS USERS TO NOT RELY SOLELY ON AUDIBLE ALARMING. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE ARE NO DESIGN, MFG, MATERIALS, OR LABELING PROBLEMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A LOSS OF AUDIO AFTER RECEIVING A VISUAL "SPEAKER MALF." INOP. NO PT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1