BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURAPLEX

    MDR report key: 21426527 · Received February 20, 2025

    Report

    Report Number
    1314417-2025-00006
    Event Type
    Death
    Date Received
    February 20, 2025
    Date of Event
    January 19, 2025
    Report Date
    April 8, 2025
    Manufacturer
    SUNMED AP, LTD.
    Product Code
    BTM
    PMA / PMN Number
    N/A
    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

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUSCITATION BAG W/MASK. 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 20 FEB 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 "2 BAGS THEY RECEIVED DID NOT HAVE THE FACE MASK IN THE BAGS, DELAYING PATIENT CARE" REGARDING PART 2442-BVM1500 WAS NOT CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THERE IS NO VISUAL AID OR WEIGHING SYSTEM TO DETERMINE IF ALL OF THE REQUIRED COMPONENTS ARE PRESENT IN THE FINISHED GOOD. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE HIGH WHICH DOES REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 7 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

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUSCITATION BAG W/MASK. 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 20 FEB 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

    (B)(6), HAS REPORTED "EMS SERVICES WAS AT A CALL, NEEDED A BVM. 2 BAGS THEY RECEIVED DID NOT HAVE THE FACE MASK IN THE BAGS, DELAYING PATIENT CARE. (B)(6) CONFIRMED THERE WAS A DEATH INVOLVED AFTER THE PATIENT WAS BROUGHT TO THE HOSPITAL." AS THERE IS A EPORT OF TWO BAGS WITH SAME ISSUE WE WILL SUBMITTING 2 MDR REPORTS TOR THIS INCIDENT. THE SECOND MDR RELATED TO THIS INCIDENT IS 1314417-2025-00007.

    Description of Event or Problem · 0

    ROULETTE CHEMICAL ENG CO, HAS REPORTED "EMS SERVICES WAS AT A CALL, NEEDED A BVM. 2 BAGS THEY RECEIVED DID NOT HAVE THE FACE MASK IN THE BAGS, DELAYING PATIENT CARE. DAWN CONFIRMED THERE WAS A DEATH INVOLVED AFTER THE PATIENT WAS BROUGHT TO THE HOSPITAL." AS THERE IS A REPORT OF TWO BAGS WITH SAME ISSUE, WE WILL SUBMITTING 2 MDR REPORTS TOR THIS INCIDENT. THE SECOND MDR RELATED TO THIS INCIDENT IS 1314417-2025-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425138 CURAPLEX CURAPLEX BVM, ADULT, MASK SIZE 5, UNIVERSAL CONNECTOR, 7FT O2 TUBING BTM SUNMED AP, LTD. 301-BVM1500 479693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death