BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP20

    MDR report key: 21076625 · Received January 5, 2025

    Report

    Report Number
    9610816-2024-001028
    Event Type
    Malfunction
    Date Received
    January 5, 2025
    Date of Event
    March 25, 2024
    Report Date
    February 12, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K122439
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. E1: REPORTER INSTITUTION PHONE NUMBER: (B)(6). E1: REPORTER PHONE NUMBER: (B)(6). BOX E: UPDATED INFORMATION REPORTING INSTITUTION NAME FROM : (B)(6) HOSPITAL. BOX E: UPDATED INFORMATION ADDRESS LINE 1 FROM : (B)(6).

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICE IN QUESTION. THE FSE TROUBLESHOT THE DEVICE BY TRYING TO RECONNECT THE ECG LEADS, BUT THE WAVEFORM STILL CANNOT BE DISPLAYED NORMALLY. THE KIND OF SENOR BEING USED AND SPECIAL TECHNOLOGIES INVOLVED WITHIN THE INCIDENT COULD NOT BE PROVIDED BY THE CUSTOMER. THE CUSTOMER COULD DID NOT MENTION THERE WAS ACTUAL HARM TO THE PATIENT OR THE LENGTH OF THE DELAY IN TREATMENT. HOWEVER, THE CUSTOMER CONFIRMED THE DELAY DID NOT IMPACT THE PATIENT OUTCOME. IT WAS NOTED THE PATIENT MADE A RECOVERY. AFTER THE MP20 WAS REPLACED, THE UNIT RETURNED TO WORKING SPECIFICATION. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ECG WAVEFORM DID NOT DISPLAY PROPERLY AFTER CONNECTING THE CABLE, WHICH DELAYED TREATMENT. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS QUALITY AND REGULATORY PERSONNEL VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MP20 INDICATING THE ECG WAVEFORM DID NOT DISPLAY PROPERLY AFTER CONNECTING THE CABLE, WHICH DELAYED TREATMENT. GOOD FAITH EFFORTS WERE PERFORMED AND REVEALED THERE WAS NO HARM TO PATIENT. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136564 INTELLIVUE MP20 INTELLIVUE MP20 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 862134

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Other