BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNTELLIVUE PHILIPS PATIENT MONITOR 6000 SERIES

    MDR report key: 21814024 · Received April 10, 2025

    Report

    Report Number
    MW5168782
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 4, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AN INCORRECT LASER MARKING WAS DISCOVERED ON PHILIPS INTELLIVUE 6000 SERIES PATIENT MONITORS. THE BACK PANEL DISPLAYS A SYMBOL FOR A 12-LEAD ECG, EVEN THOUGH THE PATIENT MONITORS ONLY SUPPORT A 6-LEAD ECG. THIS COULD LEAD TO INCORRECT TREATMENT OR DELAYS, AS USERS COULD MISTAKENLY ASSUME THEY CAN PERFORM A 12-LEAD ECG. THE CORRESPONDING "FIELD SAFETY NOTICE" FROM PHILIPS, WITH REFERENCE NUMBER 2025-CC-HPM-003. PHILIPS ALSO REFERS TO "FCO86202041". THANKS, (B)(6). REF REPORTS: MW5168781, MW5168783.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 5/12/2025 FOR REPORT MW5168782 TO UPDATE REPORTER'S NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091683 LNTELLIVUE PHILIPS PATIENT MONITOR 6000 SERIES MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH 867313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown