BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1854446 · Received September 3, 2010

    Report

    Report Number
    1721504-2010-00262
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K920977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVAL/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. EVAL, METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAD TWO CASES THIS PAST WEEK WHERE THEY HAD TO RE-ZERO THE TRANSDUCER NUMEROUS TIMES DURING USE. THE PRESSURES WERE ABNORMALLY LOW. ONCE THE TRANSDUCER WAS RESET TO ZERO, IT WOULD DRIFT BACK TO AN ABNORMALLY LOW READING. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THIS HAPPENED FIVE (5) TIMES DURING ONE CASE LAST FRIDAY AND TWO TIMES DURING A CASE THEY HAD YESTERDAY. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. CUSTOMER REPORTED THREE (3) TOTAL DEFECTIVE DEVICES. CUSTOMER IS NOT RETURNING ANY DEVICES FOR EVAL/INVESTIGATION. THEREFORE, THIS SINGLE REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F778396

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA