BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP5

    MDR report key: 7099175 · Received December 8, 2017

    Report

    Report Number
    9610816-2017-00389
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Report Date
    November 16, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BZQ
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPEAKER DID NOT WORK ANYMORE. THERE WAS NO REPORT OF AN ADVERSE EVENT. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881345 MP5 PATIENT MONITOR BZQ PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1