BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 16828158 · Received April 27, 2023

    Report

    Report Number
    3012307300-2023-04677
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Report Date
    June 30, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE TAMPER SEALS ARE BOTH INTACT. A NON-OEM POWER CORD WAS IDENTIFIED AND WAS DISPOSED OF, REPLACED WITH OEM COMPONENT 21-2145-01. EVENT HISTORY LOG REVIEW: SEVERAL 'LOW BATTERY CHANGE' ALARMS FOLLOWED BY SEVERAL 'DEPLETED BATTERY' ALARMS. EVALUATION TEST: POWER UP PROCESS, CHECKED BATTERY DIAGNOSTICS. CANNOT DUPLICATE 'DEPLETED BATTERY' OR 'LOW BATTERY' ALARMS. BATTERY WAS AT 13% CAPACITY AND ALL VALUES WERE IN SPEC. MOST PROBABLE CAUSE IS USER ERROR, AND THAT THE CUSTOMER DEPLETED THE BATTERY. THE BATTERY WAS REPLACED AS A PREVENTIVE ACTION. PERFORMED POWER UP PROCESS, PM AND ALL FUNCTIONAL TESTS WHICH PASSED. PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR REVIEW WAS NOT PERFORMED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS YEAR AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE EXHIBITED AN ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046544 MEDFUSION PUMP, INFUSION FRN ST PAUL 4000-0106-01 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown