BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX800 PATIENT MONITOR

    MDR report key: 13310830 · Received January 20, 2022

    Report

    Report Number
    9610816-2022-00032
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    August 19, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    UDI-DI
    00884838020733
    PMA / PMN Number
    K150310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED VIA REMOTE SUPPORT BY A PHILIPS RESPONSE CENTER ENGINEER (RCE). THE CUSTOMER STATED THAT A "SPEAKER MALFUNCTION" INOP WAS DISPLAYED ON THE MX800 AND NO SOUND WAS COMING FROM THE DEVICE. THE RCE RECOMMENDED THAT THE CUSTOMER RESTART THE MONITOR WHICH RESOLVED THE REPORTED ISSUE. THE "SPEAKER MALFUNCTION" INOP WAS NO LONGER DISPLAYED AND SOUND WAS EMITTED BY THE MONITOR. BASED ON THE AVAILABLE DETAILS, THE EXACT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. NO SUBSEQUENT CALLS WERE RECEIVED FROM THE CUSTOMER REGARDING THE REPORTED DEVICE AND ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A "SPEAKER MALFUNCTION" INOP WAS DISPLAYED ON THE INTELLIVUE MX800 PATIENT MONITOR AND NO SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108694 INTELLIVUE MX800 PATIENT MONITOR INTELLIVUE MX800 PATIENT MONITOR DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 865240 00884838020733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown