BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 12488272 · Received September 17, 2021

    Report

    Report Number
    1218950-2021-10934
    Event Type
    Death
    Date Received
    September 17, 2021
    Date of Event
    March 6, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE MANUFACTURER, PHILIPS¿ FIRST CONTACT FROM THE HOSPITAL IN REGARD TO THIS INCIDENT WAS ON (B)(6), 2021. THIS WAS AN INFORMAL REQUEST TO INVESTIGATE TO A PHILIPS CLINICAL APPLICATION SPECIALIST (CAS) WHILST VISITING (B)(6) HOSPITAL ON ANOTHER MATTER. THE QUESTION FROM THE MATRON WAS WHETHER A VENTRICULAR STANDSTILL WOULD CAUSE AN ALARM AND, IF SO, HOW LONG IT WOULD LAST FOR. A GENERAL ECG WAVEFORM STRIP AND AN ASYSTOLE ALARM STRIP, PRINTED OUT AROUND THE TIME OF THE INCIDENT, WAS EMAILED TO THE CAS ON (B)(6), 2021. THE ASYSTOLE ALARM STRIP SHOWED THIS ALARM GENERATED AT THE TIME OF THE VENTRICULAR STANDSTILL, BUT WITHOUT THE CLINICAL AUDIT LOGS, THE DURATION OF THIS ALARM AND ANY OTHER ACTIONS TAKEN AROUND THE TIME OF THIS ALARM ARE UNKNOWN. THE CONFIGURATION OF THE PIC IX WAS REVIEWED BY THE CAS AT THE TIME OF THIS FIRST SITE VISIT AND FOUND THE SYSTEMS FUNCTIONING AS DESIGNED. RED ALARMS WERE ENABLED AND CANNOT BE TERMINATED WITHOUT END USER INTERVENTION. FURTHER REVIEW OF THE AVAILABLE INFORMATION FOUND THAT THERE WAS NOT A STRIP FOR THE INCIDENT ON (B)(6), 2021 TO REVIEW. A STRIP WAS PROVIDED FOR (B)(6), 2021 13:09:13 THAT REVEALED AN ECG WAVEFORM WITH BEAT LABELS. A (ARTIFACT), M (MISSED), ? (QUESTIONABLE), AND ONE BEAT LABELED N (NORMAL) ALONG WITH A PERIOD OF VENTRICULAR STANDSTILL. THE STRIPS DO NOT INCLUDE THE RESPONSE TAKEN BY THE USER NOR THE LENGTH OF TIME THE ALARM SOUNDED. PHILIPS WAS NOT NOTIFIED OF THE (B)(6) 2021 INCIDENTS UNTIL GREATER THAN THREE MONTHS FOLLOWING THE EVENTS. AS A RESULT, CLINICAL AUDIT LOGS REQUIRED FOR A COMPLETE INVESTIGATION WERE NO LONGER AVAILABLE. SELF-TERMINATING ALARMS PER THE REPORT, HOSPITAL MEDICAL ENGINEERS WERE ASKED TO REVIEW THE TELEMETRY AND THE HOSPITAL MEDICAL ENGINEERS NOTED THAT ON (B)(6), 2021, THE MONITORS ALARM HAD TRIGGERED AND THAT IT WAS A SELF-TERMINATING ALARM. PHILIPS IS INTERPRETING THIS DESCRIPTION AS THE ALARM STOPPED ON ITS OWN ACCORD WITHOUT USER INTERACTION. ANY VENTRICULAR STANDSTILL OF 4-10 SECONDS OF DURATION WOULD MEET THE DEFINITION OF ASYSTOLE WHICH IS A RED ARRHYTHMIA ALARM. THERE IS NOT A CONFIGURATION TO CHANGE ASYSTOLE OR ANY OTHER RED ARRHYTHMIA ALARM TO SELF-TERMINATE FOR A TELEMETRY / CENTRAL STATION SETUP. IN SUMMARY, THE PRODUCT IS NOT DESIGNED TO SELF-TERMINATE RED ALARMS NOR IS PHILIPS ABLE TO REPRODUCE THE DESCRIBED BEHAVIOR. (B)(6) HOSPITAL SITE VISIT PHILIPS SUPPORT PERSONNEL PERFORMED A SITE VISIT TO (B)(6) HOSPITAL ON (B)(6), 2021. AN ECG SIMULATOR WAS UTILIZED TO TEST THE CUSTOMER¿S SYSTEM USING THE SAME EQUIPMENT THAT WAS USED ON THE PATIENT IN (B)(6). AN ASYSTOLE ALARM WAS GENERATED, AND THE SIMULATOR WAS RESET TO NORMAL SINUS RHYTHM AND THE ALARM CONTINUED EVEN THOUGH THE ASYSTOLE CONDITION HAD ENDED. TESTING REVEALED NO SELF-TERMINATING OF ALARMS. THE DEVICES WERE FOUND TO PERFORM AS EXPECTED. THE CONFIGURATION WAS FURTHER REVIEWED BY THE BUSINESS UNIT CLINICAL SPECIALIST FROM THE DATA COLLECTED DURING THIS SITE VISIT AND THE INITIAL ASSESSMENT OF RED ALARMS CANNOT BE TERMINATED WITHOUT INTERVENTION WAS VERIFIED. WHILE THE ORIGINAL DESCRIPTION OF THE ISSUE WAS REPORTED AS THE INFORMATION CENTER IX; THIS ISSUE IS WITH ALARM DETECTION AND COMMUNICATION FROM THE TELEMETRY TO THE PIC IX. WHEN TELEMETRY IS USED WITH PIC IX, THE ALARM SETTINGS ARE SENT FROM THE PIC. RED ALARMS CANNOT BE SET TO SELF TERMINATE IN THE PIC CONFIGURATION. PHILIPS HEALTHCARE INVESTIGATED THE REPORTED INCIDENT AND CONCLUDED THAT THE DEVICE OPERATES PER SPECIFICATION. A FULL INVESTIGATION INTO THE ALLEGED SELF-TERMINATING ALARM INCIDENT WAS NOT POSSIBLE AS THE REQUIRED LOGS WERE NOT OBTAINED WHEN THE INCIDENT OCCURRED. THERE IS NOT A CONFIGURATION AVAILABLE TO ENABLE ASYSTOLE OR ANY OTHER RED ARRHYTHMIA ALARM TO SELF-TERMINATE FOR TELEMETRY / CENTRAL STATION MONITORING. TERMINATION OF ASYSTOLE OR OTHER RED ARRYTHMIA ALARM WITH THE CURRENT CONFIGURATION REQUIRES END USER INTERVENTION, AS SHOWN WITH THE SIMULATION TEST WITH NHS PERSONNEL PRESENT. BASED ON THE CURRENT CONFIGURATIONS OF THE SYSTEM, IF A RED ALARM IS SILENCED BY THE USER BUT PERSISTS, THE EXPECTED BEHAVIOR IS FOR THE AUDIBLE ALARM TO END, THE VISUAL ALARM TO REMAIN AND A BRIEF SERIES OF AUDIBLE TONES TO BE PROVIDED EVERY 3 MINUTES, WHICH STOP AFTER SEVERAL SECONDS ON THEIR OWN AS LONG AS THE CONDITION REMAINS. AN ON-SITE VISIT FOUND THE EQUIPMENT TO BE OPERATING AS DESIGNED. NO TROUBLE WAS FOUND. THE ALLEGATION THAT THE SPECIFIED VENTRICULAR STANDSTILL ALARM WAS SELF-TERMINATING IS NOT POSSIBLE IN CONSIDERATION OF THE CONFIGURATION AND USE AT THIS FACILITY. THIS IS CONSIDERED CLINICAL APPLICATION UNDERSTANDING OF THE SYSTEM. INFORMATION WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    THE CORONER REPORTED A PATIENT DEATH. THE DECEASED WAS ADMITTED TO (B)(6) HOSPITAL ON (B)(6) 2021 WHERE THE PATIENT WAS TREATED FOR HEART FAILURE. THE PATIENT COMMENCED ON CONTINUAL CARDIAC MONITORING FROM (B)(6), WHERE TWO PERIODS OF VENTRICULAR STANDSTILL WERE RECORDED BUT WERE MISSED DUE TO A COMBINATION OF POLICY, STAFFING, WORKPLACE AND EQUIPMENT ISSUES. THE PATIENT SUFFERED A CARDIAC ARREST ON (B)(6) 2021 AND WAS TREATED ON INTENSIVE CARE UNIT (ICU) FOR 22 DAYS IN TOTAL. DESPITE TREATMENT, THE PATIENT DETERIORATED RAPIDLY AND DIED AT 13:40, (B)(6) 2021. THE CORONER BELIEVED THAT HAD THE PERIODS OF VENTRICULAR STANDSTILL BEEN DETECTED, THE PATIENT WOULD HAVE BEEN ADMITTED TO THE CRITICAL CARE UNIT (CCU) FOR MONITORING, BUT SUBSEQUENT CARDIAC ARRESTS COULD NOT HAVE BEEN PREVENTED. WHILE THE CAUSE OF DEATH WAS DETERMINED TO BE NATURAL CAUSES, THE CORONER INDICATED THAT EVIDENCE REVEALED MATTERS GIVING RISE TO CONCERN. IN THE CORONER'S OPINION THERE IS A RISK THAT FUTURE DEATHS WILL OCCUR UNLESS ACTION IS TAKEN.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CORONER REPORTED A PATIENT DEATH. THE DECEASED WAS ADMITTED TO (B)(6) HOSPITAL ON (B)(6) 2021 WHERE THE PATIENT WAS TREATED FOR HEART FAILURE. THE PATIENT COMMENCED ON CONTINUAL CARDIAC MONITORING FROM (B)(6), WHERE TWO PERIODS OF VENTRICULAR STANDSTILL WERE RECORDED BUT WERE MISSED DUE TO A COMBINATION OF POLICY, STAFFING, WORKPLACE AND EQUIPMENT ISSUES. THE PATIENT SUFFERED A CARDIAC ARREST ON (B)(6) 2021 AND WAS TREATED ON INTENSIVE CARE UNIT (ICU) FOR 22 DAYS IN TOTAL. DESPITE TREATMENT, THE PATIENT DETERIORATED RAPIDLY AND DIED AT 13:40, (B)(6) 2021. THE CORONER BELIEVED THAT HAD THE PERIODS OF VENTRICULAR STANDSTILL BEEN DETECTED, THE PATIENT WOULD HAVE BEEN ADMITTED TO THE CRITICAL CARE UNIT (CCU) FOR MONITORING, BUT SUBSEQUENT CARDIAC ARRESTS COULD NOT HAVE BEEN PREVENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386309 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death