BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (EU)

    MDR report key: 20226731 · Received September 16, 2024

    Report

    Report Number
    9611174-2024-01517
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 16, 2024
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY AND FOUND THE ISSUE DURING DEVICE EVALUATION. THE SUBJECT DEVICE WILL NOT BE SENT BACK TO OLYMPUS FOR FURTHER EVALUATION AND REPAIR. A ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED PUMP HEAD FAILURE, THE PUMP HEAD WAS FAULTY/DAMAGED/WORN AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392571 FLUSHING PUMP OFP-2 (EU) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown