BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP5

    MDR report key: 8439507 · Received March 21, 2019

    Report

    Report Number
    9610816-2019-00082
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Report Date
    March 5, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BZQ
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. NO ADVERSE EVENT INVOLVING PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234722 MP5 PATIENT MONITOR BZQ PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1