BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2 EASY

    MDR report key: 20700864 · Received November 15, 2024

    Report

    Report Number
    2028807-2024-00069
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 17, 2024
    Report Date
    January 10, 2025
    Manufacturer
    WESTMED LLC
    Product Code
    CCK
    UDI-DI
    00709078621352
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CO2 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 15 NOV 2024 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 SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS 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 SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "THE PRODUCT FAILED TWICE" REGARDING PART 562135 WAS NOT CONFIRMED. THE ROOT CAUSE COULD POSSIBLY BE A RESULT OF CUSTOMER MISUSE. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 2 OTHER COMPLAINTS REGARDING A SIMILAR PART AND ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    H6: CO2. 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 15 NOV 2024 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 SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS 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 SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    DURING AN INTUBATION, THE PRODUCT FAILED TWICE, AND WE ARE NOT SURE IF WE HAD A BAD BATCH OR IF IT WAS THE SIZE AND CONDITION OF THE PATIENT (IT WAS A MICRO-PREMIE).

    Description of Event or Problem · 0

    DURING AN INTUBATION, THE PRODUCT FAILED TWICE, AND WE ARE NOT SURE IF WE HAD A BAD BATCH OR IF IT WAS THE SIZE AND CONDITION OF THE PATIENT (IT WAS A MICRO-PREMIE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037176 CO2 EASY PEDI CO2 EASY DETECTOR CCK WESTMED LLC 562135 478158 00709078621352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other