BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ELECTRONIC INFUSION PUMPS

    MDR report key: 23491153 · Received November 6, 2025

    Report

    Report Number
    2026095-2025-00027
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Report Date
    November 6, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; THEREFORE, THE UDI-PI IS UNAVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 06-NOV-2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CALLER NOTED "NO DETAILS OBTAINED AS CALLING DOCTOR OR EMS AS QUICKLY AS POSSIBLE." PATIENT "AND FAMILY MEMBER STATE HE ALMOST JUST FAINTED WHEN GOING TO THE BATHROOM. HE TURNED PALE WHITE AND ROOM WAS SPINNING. GUIDED THEM TO CALL DOCTOR OR EMERGENCY SERVICES IMMEDIATELY. [PATIENT] WAS ABLE TO TALK AND HAS RECOVERED A LITTLE. THEY HAVE A NUMBER TO THE ANESTHESIOLOGIST AND WILL CALL THEM NOW. GUIDED THEM TO CALL EMERGENCY SERVICES IF CAN'T GET THE DOCTOR. PATIENT HAD SURGERY (B)(6) 2025 [AND] IS HYPERVENTILATING WHEN STANDING AND INCREASED HEART RATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385021 UNKNOWN ELECTRONIC INFUSION PUMPS ELECTRONIC INFUSION PUMPS & SYSTEMS FRN AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other