BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP5

    MDR report key: 8864350 · Received August 6, 2019

    Report

    Report Number
    9610816-2019-00207
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    December 20, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BZQ
    UDI-DI
    00884838000230
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND OBSERVED THAT THE MONITOR HAD CHIPS ON THE EXTERIOR. UPON CLOSER EXAMINATION, THE FSE DETERMINED THE MACHINE FELL FROM THE WALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TOUCH SCREEN FAILURE ON THEIR MONITOR. NO ADVERSE EVENT WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657076 MP5 PATIENT MONITOR BZQ PHILIPS MEDICAL SYSTEMS M8105A (865024) 00884838000230

    Patients

    Seq Age Sex Outcome Treatment
    1