BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODA INLINE FILT FOR CO2

    MDR report key: 16877165 · Received May 5, 2023

    Report

    Report Number
    1216677-2023-00071
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    February 21, 2023
    Report Date
    May 17, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQG
    PMA / PMN Number
    K001486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-NO SAMPLE RETURNED X-REVIEW DHR. ANALYSIS AND FINDINGS E-COMPLAINT (B)(4). DISTRIBUTION HISTORY THE COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10-17-22 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR-CIPR-001 - 322808 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW THE INCOMING INSPECTION REVIEW IS NOT APPLICABLE FOR THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION AN EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL, HOWEVER, PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THE COMPLAINT. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION AN EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL, HOWEVER, BASED ON THE STATED COMPLAINT CONDITION AND THE PHOTOS, THE UNIT WAS MOUNTED OUTSIDE THE HUMIDITY CHAMBER. THE CODA FILTER NOMINAL PRESSURE RATING IS 24 PSI, AND IT MAY HAVE BEEN OVER-PRESSURED. ALSO, BASED ON THE PHOTOS, THERE MAY HAVE BEEN LATERAL STRESS ON THE INPUT OR OUTPUT CONNECTORS. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THIS ISSUE, POTENTIALLY, MAY HAVE BEEN DUE TO OVER-PRESSURIZATION OF THE FILTER AND/OR LATERAL STRESS ON THE ON THE INPUT OR OUTPUT CONNECTORS, WHICH WOULD BE END USER ERROR. THIS IS AN ISOLATED INCIDENT. CORRECTION AND/OR CORRECTIVE ACTION COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL, HOWEVER, PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THE COMPLAINT. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    PER DETAILS RECEIVED FROM USER FACILITY ON INCOMING (B)(4). "WE RECENTLY HAD A CODA FILTER EXPLODE IN THE LAB. WE ARE NOT ENTIRELY SURE IF THE SOURCE OF THE ISSUE WAS RELATED TO THE FILTER ITSELF, THE GAS REGULATOR, OR THE INCUBATORS THEY WERE CONNECTED TO, BUT WE DO SUSPECT THAT THE FILTER MAY HAVE BEEN DEFECTIVE."

    Description of Event or Problem · 0

    PER DETAILS RECEIVED FROM USER FACILITY ON INCOMING E-COMPLAINT (B)(4) : "WE RECENTLY HAD A CODA FILTER EXPLODE IN THE LAB. WE ARE NOT ENTIRELY SURE IF THE SOURCE OF THE ISSUE WAS RELATED TO THE FILTER ITSELF, THE GAS REGULATOR, OR THE INCUBATORS THEY WERE CONNECTED TO, BUT WE DO SUSPECT THAT THE FILTER MAY HAVE BEEN DEFECTIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475219 CODA INLINE FILT FOR CO2 CODA INLINE FILT FOR CO2 MQG COOPERSURGICAL, INC. CIPR-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other