BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURAPLEX

    MDR report key: 21693862 · Received March 25, 2025

    Report

    Report Number
    1314417-2025-00015
    Event Type
    Death
    Date Received
    March 25, 2025
    Date of Event
    August 24, 2024
    Report Date
    April 25, 2025
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCK
    UDI-DI
    00810071631696
    PMA / PMN Number
    K063813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 25 MAR 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "SPONTANEOUS XXX ETCO2 MODULE ON SCREEN" REGARDING PARTS 301-5107ET AND 301-5707F-SE WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF USER ERROR. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 9 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 25 MAR 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    ETCO2 PLUGGED INTO MONITOR, ATTACHED TO A PATIENT, MONITOR (LP15) NOTED TO SPONTANEOUS XXX ETCO2 MODULE ON SCREEN. ETCO2 REPLACED AND REATTACHED TO SAME MONITOR - SAME RESULT. ADDITIONAL MONITOR OBTAINED, SECOND ETCO2 PROBE ATTACHED AND ATTACHED TO ETT - MONITOR SUCCESSFULLY DISPLAYED ETCO2 WITHOUT ISSUE. PATIENT PRONOUNCED DEAD AFTER FURTHER RESUSCITATION EFFORTS. OTHER: (B)(6). TWO SEPARATE DEVICES WERE USED IN RELATION TO THIS EVENT, THE SECOND REPORT NUMBER IS 1314417-2025-00016.

    Description of Event or Problem · 0

    ETCO2 PLUGGED INTO MONITOR, ATTACHED TO A PATIENT, MONITOR (LP15) NOTED TO SPONTANEOUS XXX ETCO2 MODULE ON SCREEN. ETCO2 REPLACED AND REATTACHED TO SAME MONITOR - SAME RESULT. ADDITIONAL MONITOR OBTAINED, SECOND ETCO2 PROBE ATTACHED AND ATTACHED TO ETT - MONITOR SUCCESSFULLY DISPLAYED ETCO2 WITHOUT ISSUE. PATIENT PRONOUNCED DEAD AFTER FURTHER RESUSCITATION EFFORTS. OTHER: (B)(6). TWO SEPERATE DEVICES WERE USED IN RELATION TO THIS EVENT, THE SECOND REPORT NUMBER IS 1314417-2025-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121728 CURAPLEX ADULT ORAL-NASAL 7FT ETCO2 FITS-ALL REFLECTIVE CONNECTOR CCK BOUND TREE MEDICAL, LLC 5707F-SE UNKNOWN 00810071631696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death