BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (ROW)

    MDR report key: 19744215 · Received July 15, 2024

    Report

    Report Number
    9611174-2024-01326
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 5, 2024
    Report Date
    January 5, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    UDI-DI
    15019778003238
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 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 DURING CLEANING AND DISINFECTION, THE SUBJECT DEVICE HAD PANEL OUT OF ORDER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390582 FLUSHING PUMP OFP-2 (ROW) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001145 15019778003238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CV-290