BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA CM10

    MDR report key: 11733662 · Received April 27, 2021

    Report

    Report Number
    1218950-2021-10433
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 7, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K151812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CARE SOLUTION CENTER DISPATCHED A FIELD SERVICE ENGINEER (FSE) FOR SUPPORT. THE ISSUE WAS RESOLVED BY THE CUSTOMER REPLACING THE UNSPECIFIED BLOOD OXYGEN PROBE, WHICH RETURNED THE DEVICE BACK TO FUNCTIONALITY. THE DEVICE REMAINS ON SITE AND IN USE AT THIS CUSTOMER SITE. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IN THE MORNING WARD ROUND, THE BLOOD OXYGEN VALUE OF THE MONITOR WAS FOUND TO BE 89%, AND THE PATIENT WAS OBSERVED TO BREATHE SMOOTHLY. THE PATIENT WAS IMMEDIATELY REPLACED WITH ANOTHER ECG MONITOR TO MEASURE THE BLOOD OXYGEN SATURATION AND THE BLOOD OXYGEN VALUE WAS 97%. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IN THE MORNING WARD ROUND, THE BLOOD OXYGEN VALUE OF THE MONITOR WAS FOUND TO BE 89%, AND THE PATIENT WAS OBSERVED TO BREATHE SMOOTHLY. THE PATIENT WAS IMMEDIATELY REPLACED WITH ANOTHER ECG MONITOR TO MEASURE THE BLOOD OXYGEN SATURATION AND THE BLOOD OXYGEN VALUE WAS 97%. 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
    627304 EFFICIA CM10 EFFICIA CM10 MHX PHILIPS NORTH AMERICA LLC 863301

    Patients

    Seq Age Sex Outcome Treatment
    1