BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARTONE DOPPLER

    MDR report key: 19125182 · Received April 17, 2024

    Report

    Report Number
    1216677-2024-00017
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    February 22, 2024
    Report Date
    May 1, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KNG
    UDI-DI
    00888937001594
    PMA / PMN Number
    K024197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 08/26/2020 UNDER WO (B)(4) AND SHIPPED ON 09/08/2020. MANUFACTURING RECORD REVIEW: DHR 292527 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON SERVICE NOTES, THIS UNIT WAS AT CSI ON 03/11/2024. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE DEVICE WAS NOTED TO HAVE SIGNIFICANT DAMAGE INCLUDING THE BOARD. EXPOSURE TO HEAT AND IMPACT WAS DETERMINED TO BE CONTRIBUTING TO THE COMPLAINT CONDITION. THE HEAT SOURCE WAS NOT CONFIRMED AND THE UNIT WAS RETURNED WITHOUT THE BATTERIES TO EVALUATE THEM. HOWEVER, THE ONLY SOURCE OF HEAT MAY BE DUE TO DEFECTIVE BATTERIES OR AN EXTERNAL SOURCE EXPOSING THE DEVICE SUFFICIENT HEAT OR SOME COMBINATION OF THE 2 SCENARIOS. THE BOARD IS NOT A POTENTIAL HEAT SOURCE AND THE BACK CASING OF THE DEVICE CONFIRMS SUFFICIENT HEAT EXPOSURE TO MELT THE PLASTIC HOUSING. ROOT CAUSE IS ATTRIBUTED TO HANDLING ERROR. THE UNIT WAS NOT REPAIRABLE AND SCRAPPED OUT. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO OTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    DEVICE IS BEING RETURNED FOR REPAIR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT WAS VISIBLY SMOKING, NOT WORKING PROPERLY. NO HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00017 (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914705 CLEARTONE DOPPLER FOETAL DOPPLER SYSTEM KNG COOPERSURGICAL, INC. CT250-3 N/A 00888937001594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown