BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 17289643 · Received July 10, 2023

    Report

    Report Number
    1218950-2023-00481
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 16, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX, INDICATING THE "YELLOW AND BLUE ALARMS DISPLAY WITHOUT AUDIBLE TONE." A PHILIPS REMOTE SERVICE ENGINEER (RSE) REMOTED INTO PICIX WITH CUSTOMER PERMISSION. THE RSE VERIFIED THE PIIC IX CONFIGURATION SETTINGS AND INSTRUCTED THE BIOMED TO CONNECT MX40 TRANSMITTER TO PATIENT SIMULATOR THEN ASSIGN TO AVAILABLE PIIC IX COMPUTER SECTOR FOR TESTING. THE BIOMED ASSIGNED MX40 TRANSMITTER THEN SET SIMULATOR FOR HR > 140 BUT NO TACHYCARDIA ALARM WAS DISPLAYED. THE RSE RECOMMENDED REBOOTING THE PIIC IX. THE BIOMED CONFIRMED ALARM BEHAVIOR WAS AS EXPECTED, AND AUDIBLE TONES HEARD FOR ALARMS. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM SEEMS TO BE A SOFTWARE ISSUE, SINCE THE ISSUE WAS RESOLVED VIA A REBOOT OF THE DEVICE. AFTER THE REBOOT THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS. B5 DESCRIBE EVENT OR PROBLEM WAS CORRECTED TO ADDRESS THE REPORTABLE EVENT OF FAILURE TO ALARM. THE SECONDARY ISSUE OF ALARMS INTERMITTENTLY BEING SILENCED AND TERTIARY ISSUE OF ALARMS STAYING AT YELLOW LEVEL HAVE BEEN ADDRESSED IN SEPARATE RECORDS.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED YELLOW AND BLUE ALARMS DISPLAY WITHOUT AUDIBLE TONE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. WHEN THE BIOMED PERFORMED TESTING WITH A SIMULATOR NO TACHYCARDIA ALARM WAS DISPLAYED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RED ALARMS ARE INTERMITTENTLY BEING SILENCED WITHOUT INTERACTION FROM THE USER, AND YELLOW AND BLUE ALARMS DISPLAY WITHOUT AUDIBLE TONE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE BIOMED. USING A SIMULATOR, THE BIOMED INCREASED HR FROM 120-160, ONLY ANNOUNCED A YELLOW LEVEL ALARM. CLINICAL AUDIT LOGS WERE REVIEWED AND FOUND ENTRIES THAT ALARMS WERE SILENCED. THE RSE VERIFIED THE PIIC IX CONFIGURATION SETTINGS AND INSTRUCTED THE BIOMED TO CONNECT MX40 TRANSMITTER TO PATIENT SIMULATOR THEN ASSIGN TO AVAILABLE PIIC IX COMPUTER SECTOR FOR TESTING. BIOMED ASSIGNED MX40 TRANSMITTER THEN SET SIMULATOR FOR HR 140 BUT NO TACHYCARDIA ALARM WAS DISPLAYED. THE RSE RECOMMENDED REBOOTING THE PIIC IX. THE RSE REBOOTED THE PICIX. TESTING WAS PERFORMED USING THE SAME PROCEDURE, HEART RATE 120 INCREASED TO 160 AND ANNOUNCED A RED LEVEL ALARM. THE BIOMED CONFIRMED ALARM BEHAVIOR WAS AS EXPECTED, AND AUDIBLE TONES HEARD FOR ALARMS. BASED ON TESTING IT APPEARS THE REBOOT RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181033 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown