BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WA4000 20# N20 CONN

    MDR report key: 10095898 · Received May 28, 2020

    Report

    Report Number
    1216677-2020-00126
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    April 9, 2020
    Report Date
    January 30, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937014020
    PMA / PMN Number
    K813024
    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

    INVESTIGATION INSPECT RETURNED SAMPLES DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 2008. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: UNIT WAS RETURNED TO CSI UNDER LOG 81344 2/9/2016 FOR A LEAK ON THE LL100 SECTION OF THE UNIT AND THE "ON/OFF" VALVE IN THE CONSOLE. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT WAS CONTAMINATED WITH COLD SOAK RESIDUE INSIDE THE LL100 SECTION OF THE UNIT. ROOT CAUSE: THE ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. THE LL100 SECTION IS TO BE WIPED DOWN WITH A DISINFECTANT ONLY. OTHER METHODS ARE NOT RECOMMENDED INCLUDING COLD SOAKS. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, CLEANED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: "DEFROST BUTTON IS NOT DEFROSTING". 1216677-2020-00126-1 900509-4 WA4000 20 N20 CONN (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEFROST BUTTON IS NOT DEFROSTING. (B)(4). WA4000 20 N20 CONN 900509-4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558515 WA4000 20# N20 CONN WA4000 20# N20 CONN GEH COOPERSURGICAL, INC. 900509-4 N/A 00888937014020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other