BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEHEALTH CENTER PRODUCT LICENSE

    MDR report key: 20607982 · Received November 5, 2024

    Report

    Report Number
    1125873-2024-00002
    Event Type
    Death
    Date Received
    November 5, 2024
    Date of Event
    October 4, 2024
    Report Date
    December 10, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    MSX
    UDI-DI
    00884838102910
    PMA / PMN Number
    K211046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEGAL MANUFACTURER IN SECTION D2 AND G1 WAS MENTIONED AS VISICU, INC (PREVIOUS LM - ADDRESS - 217 EAST REDWOOD ST. SUITE 1900, BALTIMORE, MD, 21202) INSTEAD OF PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V (UPDATED LM - ADDRESS - HIGH TECH CAMPUS 36, EINDHOVEN, NETHERLANDS, 5656AE). DURING THE INTERNAL REVIEW OF THE RECORD, IT WAS NOTICED AND HENCE SUBMITTING THE CORRECTION MDR. SECTIONS D2 AND G1 ARE UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROGRESS. HOWEVER, INITIAL INVESTIGATION IDENTIFIED THAT THE ELERT SYSTEM IS NOT THE PRIMARY NOTIFICATION SYSTEM. GATHERING OF ALL REQUIRED INFORMATION IS PENDING AND ALL THE DETAILS WILL BE PROVIDED IN FINAL REPORT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION RESULTS ARE UPDATED IN SECTION: D3, F7, G1, G6, H2, H3 & H6. INVESTIGATION SUMMARY: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE ECAREMANAGER INDICATING THAT THE BEDSIDE NURSE PUSHED THE ALERT BUTTON, BUT NO ALERT WAS RECEIVED REMOTELY AND THE PATIENT SUBSEQUENTLY PASSED AWAY. ADDITIONAL INFORMATION STATES THAT INITIALLY THE BUTTON WAS NOT FULLY DEPRESSED, BUT SEVERAL MINUTES LATER, THE BUTTON WAS ACTUALLY PUSHED, THEN THE REMOTE NURSE CONNECTED AND WORKED WITH THE BEDSIDE TEAM. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE REMOTE SERVICE ENGINEER DISCUSSED THIS ISSUE WITH THE CUSTOMER. IT WAS CONFIRMED BY THE CUSTOMER THAT THE ALERT BUTTON HAD BEEN TESTED MULTIPLE TIMES AND IT WAS WORKING. THE CUSTOMER MENTIONED THAT THE ISSUE LIKELY WAS CAUSED BY THE BUTTON NOT BEING FULLY PRESSED DURING THE REPORTED EVENT. THE BUTTONS ARE MECHANICAL, AND IT'S BEEN SEEN IN THE PAST THAT THE MECHANISM DOESN'T TRIGGER THE NOTIFICATION IF THEY'RE NOT FULLY PRESSED. FURTHER PHILIPS REMOTE SERVICE ENGINEER REVIEWED SOFTWARE AND LOGS, IT SHOWED NO ERRORS OR ABNORMALITIES WITHIN THE EVENT TIMELINE. ALL ALERTS QUERY WERE ALSO PULLED FOR THE IDENTIFIED BED AND FOUND THAT THERE WERE TWO CONFIRMED ALERTS RECEIVED BUT NOT AT THE TIME OF THE INCIDENT. HENCE, IT WAS CONFIRMED THAT THE BUTTON WAS PHYSICALLY WORKING AS CUSTOMER INFORMED, AND IT WAS NOT FULLY DEPRESSED DURING THE INCIDENT RESULTING IN THE FAILURE OF NOTIFICATION TRIGGER. THE CUSTOMER WORKED WITH THE STAFF TO INVESTIGATE THE BUTTON FOR FAILURE, AND CONFIRMED THE BUTTON WAS WORKING PROPERLY IN ALL OF THEIR TESTING. THERE HAVE BEEN NO FURTHER INSTANCES OF ALERT BUTTON FAILURE WITH THIS OR ANY OTHER ROOM. THUS, THE INCIDENT WAS DETERMINED TO BE A CASE OF HUMAN ERROR, AS THE USER DID NOT FULLY DEPRESS THE BUTTON. THE ECAREMANAGER IS A TERTIARY NOTIFICATION SYSTEM AND IT¿S NOT INTENDED TO BE USED AS A REPLACEMENT FOR NURSES AT THE BEDSIDE. THE ALERT IS A THIRD-PARTY DEVICE SUPPLIED BY A/V VENDOR AND AS PER ECAREMANAGER 4.5.0 CLINICAL USER GUIDE REV.D, SECTION: THIRD-PARTY EQUIPMENT AND TECHNOLOGY, IT CLEARLY STATS THAT INSTRUCTIONS FOR THE CARE AND MAINTENANCE OF THIS EQUIPMENT IS THE RESPONSIBILITY OF THE VENDOR. EVEN IF THE ALERT BUTTON EXPERIENCED A MECHANICAL FAILURE, IT WILL NEVER RESULT IN A PATIENT DEATH GIVEN OUR INTENDED USE AND IFU STATEMENTS. THE ECAREMANAGER SYSTEM ALERT CALL BUTTON IS AN ALTERNATE COMMUNICATION TOOL AND IT IS STRONGLY RECOMMENDED THAT THE BEDSIDE CLINICIANS FOLLOW THE ESTABLISHED PROTOCOL IF THE ALERT IS NOT ACKNOWLEDGED IN A TIMELY MANNER. HOWEVER, THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND THERE WAS NO EVIDENCE OF FAILURE OF ECAREMANAGER AND ALERT BUTTON. GOOD FAITH EFFORTS FOR ADDITIONAL INFORMATION WERE PERFORMED BUT FURTHER INFORMATION WAS NOT RECEIVED. THEREFORE, BASED ON SUBSEQUENT TESTING AND USE OF THE ALERT CALL BUTTON, SOFTWARE AND LOG REVIEW, THE DEVICE WAS FOUND TO BE WORKED AS DESIGNED, WITHOUT MALFUNCTION. THEREFORE, ALTHOUGH A PATIENT DEATH WAS REPORTED WITH LIMITED CLINICAL DETAILS, THE DEATH IS UNRELATED TO THE ECAREMANAGER SYSTEM. THE CAUSE OF THE REPORTED PROBLEM WAS USER ERROR. RISK ASSESSMENT HAS BEEN PERFORMED AND DEEMED AS ACCEPTABLE AS PER THE RISK MANAGEMENT MATRIX. BASED ON ALL THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SECTIONS D4 AND G4 ARE UPDATED IN THIS REPORT. IN SECTION G4, K012171 WAS MENTIONED AS 510K NUMBER INSTEAD OF K211046. UPDATED AS K211046. IN SECTION D4, (B)(4) WAS MENTIONED INSTEAD OF (B)(4). UPDATED AS (B)(4). DURING THE INTERNAL REVIEW OF THE RECORD, IT WAS NOTICED. HENCE DATA IS CORRECTED AND SUBMITTED FOR UPDATE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TO PHILIPS THAT, THE BEDSIDE NURSE PUSHED THE ELERT BUTTON, BUT NO ALERT WAS RECEIVED REMOTELY AND THE PATIENT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47230 TELEHEALTH CENTER PRODUCT LICENSE ECAREMANAGER MSX PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 00884838102910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death