BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 12638231 · Received October 15, 2021

    Report

    Report Number
    9610816-2021-10429
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    October 5, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SPEAKER MALFUNCTION INOP ON THE INTELLIVUE MULTI MEASUREMENT SERVER X3. NO ALARM SOUND CAME FRO THE DEVICE. THE DEVICE WAS REPORTED NOT TO BE IN USE ON A PATIENT. NO PATIENT INVOLVEMENT.

    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 INOP ON THE INTELLIVUE MULTI MEASUREMENT SERVER X3. NO ALARM SOUND CAME FRO THE DEVICE. THE DEVICE WAS REPORTED NOT TO BE IN USE ON A PATIENT. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540133 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown