BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX C ST EFP

    MDR report key: 17594729 · Received August 22, 2023

    Report

    Report Number
    1218950-2023-00589
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 27, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE TO THE CUSTOMER AND CONFIRMED THAT THE SPEAKER WAS REPLACED, CAT5 CABLE CHANGED WITH NO RESULTS. THE RCS ADVISED THE BIOMED TO GO TO CLOSET WHERE PC'S RESIDE. HE FOUND THE REMOTE SPEAKER CABLE WAS NOT PLUGGED INTO PC. THE BIOMED WAS PROVIDED INSTRUCTIONS TO REPLUG THE CABLE TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. PLUGGING IN THE CABLE RESOLVED THE ISSUE. RESULTS OF FUNCTIONAL TESTING INDICATE NO MALFUNCTION OF THE DEVICE. A GOOD FAITH EFFORT (GFE) CONDUCT CONFIRMED THAT IT IS UNKNOWN, WHO, HOW OR WHEN THE CONNECTION WAS UNPLUGGED OR IF IT WAS OVERLOOKED DURING INSTALLATION. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS AN UNPLUGGED CABLE. THE REPORTED PROBLEM WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING ¿RED AND YELLOW ALARM BANNERS ARE APPEARING, HOWEVER, THERE IS NO AUDIBLE SOUND.¿ THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50419 PIC IX C ST EFP PIC IX C ST EFP MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown