BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 16181856 · Received January 17, 2023

    Report

    Report Number
    1218950-2023-00027
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 8, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(6).

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION THIS COMPLAINT RECORD WAS REVIEWED, AND IT WAS DETERMINED THAT THE DEVICE REPORTED TO HAVE HAD A SCREEN FREEZE WAS THE PIC IX. SCREEN FREEZES FOR THE PIC IX IS NOT A REPORTABLE EVENT, THE REPORTS WERE REPORTED IN ERROR. RATIONALE: ALL CENTRALIZED PROCESSING OF DATA AND COMMUNICATION WITH CONNECTED DEVICES HALTS. WHEN THIS OCCURS, PRIMARY MONITORING AT THE BEDSIDES CONTINUE WITH BOTH AUDIBLE AND VISUAL INOP'S ANNOUNCING THE LOSS OF CENTRALIZED MONITORING. IF M4841A TELEMETRY ARE USED UPON LOSS OF COMMUNICATION WITH THE CENTRAL, THE DEVICE WILL AUDIBLY DOUBLE BEEP. IF THE MX40 IS IN USE, THE DEVICE DISPLAY WILL ACTIVATE AND ENTER MONITORING MODE WHERE LOCAL ALARMING WILL BECOME ENABLED AND A VISUAL MESSAGE OF "NO CENTRAL MONIT" IS DISPLAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIIC IX SCREEN WAS FREEZING. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A NEEDED C.03.08.BIOS UPDATE. THE DEVICE WAS FULLY OPERATIONAL AFTER REPAIRS WERE COMPLETED IN THE PERFORMED BIOS UPDATE. THE ISSUE WAS ALREADY INVESTIGATED AND ADDRESSED WITH A RETROFIT ON FAILURE FCO86201964A.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE IS NO ALARMING OF THE CENTRAL SURVEILLANCE. 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
    1134628 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS MEDICAL SYSTEMS 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown