BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA CM10

    MDR report key: 15316579 · Received August 29, 2022

    Report

    Report Number
    1218950-2022-00847
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 26, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K151812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE REPORTED PROBLEM. THE RCE CONFIRMED THAT THE SPEAKER WAS DEFECTIVE. THE RCE ADVISED THE CUSTOMER TO ORDER A NEW SPEAKER. THE CUSTOMER HAS ORDERED A SPEAKER TO RESOLVE THIS ISSUE. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. THERE HAS BEEN NO SUBSEQUENT CALLS FOR THIS DEVICE/ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A SPEAKER MALFUNCTION, AN AUDIO FAILED ALARM WAS APPEARING ON THE DISPLAY. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148397 EFFICIA CM10 EFFICIA CM10 MHX PHILIPS NORTH AMERICA LLC 863301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown