BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP5

    MDR report key: 7066845 · Received November 29, 2017

    Report

    Report Number
    9610816-2017-00374
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Report Date
    November 8, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BZQ
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION WITHOUT SOUND THERE WAS NO REPORT OF AN ADVERSE EVENT. THE DEVICE WAS USED FOR PATIENT MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848929 MP5 PATIENT MONITOR BZQ PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1