BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 17479807 · Received August 8, 2023

    Report

    Report Number
    1218950-2023-00540
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 14, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE WITH THE CUSTOMER FOR DISCUSSION OF AUDIT CLINICAL LOGS EVALUATION. THE CUSTOMER ALLEGED THE ICU BED #751 ON (B)(6) 2023, DID NOT ALARM FOR A (PULSE OXYGEN SATURATION) SPO2 ALARM FROM 1:50AM TO 4AM. THE STAFF REPORTED NOT HEARING ALARMS FOR THE YELLOW ALARMS FOR THE PATIENT UNTIL THE PATIENT HAD A DESATURATION AT 4:00AM.THE RCS LOG ANALYSIS RESULTS CONCLUDED THAT THE ALARMS DID NOT ALARM AUDIBLY PER THE CUSTOMERS' EXPECTATIONS DUE TO THE VISUAL AND AUDIBLE LATCHING SETTINGS BETWEEN THE MP70 AND X2 DEVICES, AS THE CUSTOMER DID NOT ACKNOWLEDGE THE VISUAL ALARM OF THE LOW SPO2 UNTIL 3:59AM. THE CUSTOMER WAS PROVIDED WITH SCREEN SHOTS OF ALARM LATCHING, INSTRUCTED ON HOW TO CONFIRM THE ALARM LATCHING, AND TOLD THEY MUST ACKNOWLEDGE THE ALARM VISUAL EVEN IF THE AUDIBLE HAS STOPPED. THE COMPLAINT WAS ESCALATED FOR A TECHNICAL INVESTIGATION (TI). A PHILIPS NATIONAL SUPPORT SPECIALIST (NSS), FIELD SERVICE ENGINEER (FSE) AND CLINICAL SOLUTIONS CONSULTANT (CSC) WENT TO THE SITE TO EVALUATE THE DEVICES CONFIGURATION AND LOGS FOR THE ISSUE IN QUESTION. THE DEVICES MP70 AND X3 CONFIGURATION FILES, PIIC IX LOGS AND TREND FROM SPO2 WERE ANALYZED. RESULTS OF THE TI ARE THE FOLLOWING: THE RCS CONCLUSION WAS CONFIRMED BY THE NSS. VISUAL AND AUDIBLE LATCHING SETTINGS BETWEEN MP70 AND X2 RESULTED IN WHAT OCCURRED. 1-ROOT CAUSE ANALYSIS (RCA): A MISUNDERSTANDING ON THE PART OF THE CUSTOMER ON THE MEANING OF AND IMPLICATIONS OF THE MONITOR CONFIGURATION SET TO AUDIBLY SPLIT LATCHING ALARMS. 2-STRUCTURAL SOLUTION PROVIDED: THE ISSUE CAN BE RESOLVED WITH THE CUSTOMERS CURRENT SOFTWARE (SW) REVISION. 3-RESOLUTION: NO FAULT OF THE DEVICES. IT WAS DETERMINED THAT THE CSC WOULD MEET WITH THE CUSTOMER TO DETERMINE NEXT STEPS BASED ON THE MONITOR CONFIGURATION. THE PATIENT SUFFERED FROM PULMONARY ARREST WHICH LED TO CARDIAC ARREST. THE PATIENT SURVIVED THE HOSPITAL STAY. THERE WAS NO ISSUES ISSUES WITH THE PIIC IX SOUND/SPEAKER. THE BIOMED STATED THAT WHEN THIS MATTER FIRST AROSE, THE FSE CHECKED THE MONITOR LOGS AND FOUND NO ISSUES. ALARMS PARAMETERS, DESATURATION ALARMS, SIMULATION OF DECREASING SATURATION LEVELS TO TRIGGER BOTH A YELLOW ALERT AND RED ALERT ON THE MONITOR WERE DONE TO ENSURE THE NURSE CALL SYSTEM WAS FULLY FUNCTIONAL AS WELL. RESULTS SHOWED A NURSE CALL SYSTEM FOR THE ENTIRE FLOOR. THE CUSTOMER CONFIRMED THE FSE AND BIOMED DEVICES TEST RESULTS, AS WELL AS A THIRD PARTY EVALUATION; ALL DEEMED THE DEVICES WERE WORKING PER SPECIFICATIONS, AND NO MALFUNCTIONS WERE DETECTED. IT WAS INFORMED THAT NO FURTHER INCIDENTS HAVE HAPPENED SINCE AND THE DEVICE IS NOT CURRENTLY BEING USED BUT WAS USED AFTER INCIDENT. THE AREA IS NOW UNDER CONSTRUCTION. THE CSC STATED: "I HAVE BEEN IN CONTACT WITH THE CUSTOMER ABOUT THE INCIDENT AND DISCUSSED THE CONFIGURATION SETTING IN THE BEDSIDE MONITOR AND INQUIRED IF THEY WOULD LIKE THE CONFIGURATION ALARM LATCHING CHANGED. NO DETERMINATION HAS BEEN RELAYED TO ME FROM THE CUSTOMER IF THIS WOULD BE A COURSE OF ACTION THEY WOULD LIKE TO TAKE." BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A MISUNDERSTANDING ON THE PART OF THE CUSTOMER ON THE MEANING OF AND IMPLICATIONS OF THE MONITOR CONFIGURATION SET TO AUDIBLY SPLIT LATCHING ALARMS (DIDN'T ACKNOWLEDGE THE ALARM VISUAL). THE REPORTED PROBLEM WAS NOT CONFIRMED. THE ENGINEERS PROVIDED THEIR ANALYSIS FINDINGS HOWEVER WE ARE UNABLE TO CONFIRM THE FINAL DISPOSITION OF THE DEVICE BECAUSE THE CUSTOMER DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION ON A RESOLUTION. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE WITH THE CUSTOMER FOR DISCUSSION OF CLINICAL LOGS EVALUATION. THE CUSTOMER ALLEGED THAT THE ICU BED # 751 ON (B)(6) 2023, DID NOT ALARM FOR A (PULSE OXYGEN SATURATION,) SPO2 ALARM FROM 1:50AM TO 4AM. THE STAFF REPORTED THAT THEY DID NOT HEAR ALARMS FOR THE YELLOW ALARMS FOR THE PATIENT UNTIL THE PATIENTS DESATED AT 4:00AM. THE RCS LOG ANALYSIS RESULTS CONCLUDED THAT THE ALARMS DID NOT AUDIBLY ALARM PER THE CUSTOMAERS' EXPECTATIONS DUE THE VISUAL AND AUDIBLE LATCHING SETTINGS BETWEEN THE MP70 AND X2 DEVICES. THEY CUSTOMER DID NOT ACKNOWLEDGE THE VISUAL ALARM OF THE LOW SPO2 UNTIL 3:59AM. CUSTOMER WAS PROVIDED WITH SCREEN SHOT OF ALARM LATCHING, AND WAS INSTRUCTED ON HOW TO CONFIRM THE ALARM LATCHING, AND TOLD THEY MUST ACKNOWLEDGE THE ALARM VISUAL EVEN IF THE AUDIBLE HAS STOPPED. PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION A GOOD FAITH EFFORT (GFE) CONDUCTED CONFIRMED THAT THE PATIENT SUFFERED FROM PULMONARY ARREST WHICH LED TO CARDIAC ARREST. THE PATIENT SURVIVED THE HOSPITAL STAY. THERE WERE NO ISSUES WITH THE SOUND OR SPEAKER. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION (TI). A PHILIPS NATIONAL SUPPORT SPECIALIST (NSS), A PHILIPS FIELD SERVICE ENGINEER (FSE) AND A CLINICAL SOLUTIONS CONSULTANT (CSC) WENT TO THE SITE TO EVALUATE THE DEVICES CONFIGURATION AND LOGS FOR THE ISSUE IN QUESTION. THE DEVICES MP70 AND X3 CONFIGURATION FILE, PIIC IX LOGS AND TREND FROM SPO2 WERE ANALYZED AND RESULTS OF THE TI ARE THE FOLLOWING: THE RCS CONCLUSION WAS CONFIRMED BY NSS VISUAL LATCHING AND AUDIBLE LATCHING SETTINGS BETWEEN MP70 AND X2 RESULT IN WHAT OCCURRED. ROOT CAUSE ANALYSIS (RCA): A MISUNDERSTANDING ON THE PART OF THE CUSTOMER ON THE MEANING OF AND IMPLICATIONS OF THE MONITOR CONFIGURATION SET TO AUDIBLY SPLIT LATCHING ALARMS. STRUCTURAL SOLUTION PROVIDED: THE ISSUE CAN BE RESOLVED WITH THE CUSTOMERS CURRENT SW REVISION. RESOLUTION: NO FAULT OF THE DEVICES. RESOLUTION DETAILS: PHILIPS CSC WILL MEET WITH THE CUSTOMER TO DETERMINE NEXT STEPS BASED ON THE MONITOR CONFIGURATION.

    Additional Manufacturer Narrative · 0

    BASED ON THE ROOT CAUSE ANALYSIS, A MISUNDERSTANDING ON THE PART OF THE CUSTOMER ON THE MEANING OF AND IMPLICATIONS OF THE MONITOR CONFIGURATION SET TO AUDIBLY SPLIT LATCHING ALARMS; THEREFORE, ENGINEERING WILL MEET WITH THE CUSTOMER TO DISCUSS CONFIGURATION. BASED ON THIS INFORMATION, THE DEVICE FUNCTIONED AS CONFIGURED AND DEVICE FUNCTIONALITY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE CAUSE MAY BE RELATED TO USER MISUNDERSTANDING RELATED TO THE ALARM BEHAVIOR. IF ADDITIONAL INFORMATION IS OBTAINED, PLEASE REQUEST REASSESSMENT OF THE RECORD BY THE PMS CLINICAL EXPERT. 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

    THE CUSTOMER REPORTED THAT THE DEICE DID NOT ALARM WHEN PATIENT OXYGEN WAS 70 OR 80.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467042 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other