BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (US)

    MDR report key: 19751193 · Received July 16, 2024

    Report

    Report Number
    9611174-2024-01328
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 19, 2024
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    UDI-DI
    15019778004716
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D9, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: FAULTY CONTROL PANEL. THE MOST PROBABLE ROOT CAUSE TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLUSHING PUMP HAD INDICATOR ILLUMINATORS OFF. THE ISSUE OBSERVED DURING DIAGNOSTIC COLONOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLUSHING PUMP HAD INDICATOR ILLUMINATORS OFF. THE ISSUE OBSERVED DURING DIAGNOSTIC COLONOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509039 FLUSHING PUMP OFP-2 (US) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001141 15019778004716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown