BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO/VENT JR.

    MDR report key: 17083781 · Received June 7, 2023

    Report

    Report Number
    2050098-2023-00001
    Event Type
    Injury
    Date Received
    June 7, 2023
    Manufacturer
    MEDI NUCLEAR CORPORATION INC.
    Product Code
    IYT
    PMA / PMN Number
    K865107N/A
    Removal / Correction Number
    NO CORRECTIVE ACTION
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER: MEDI/NUCLEAR CORPORATION INC. STATEMENT: THIS MDR REPORT IS IN REFERENCE NUMBER 0500170000-2023-8001. THE REPORTED PROBLEM FROM THE USER FACILITY STATES THAT THE DEVICE AV-100HV WAS USED WITH A VENTILATED PATIENT. THIS IS THE CORRECT DEVICE TO USE WITH A VENTILATED PATIENT, SO THIS STATEMENT CONTRADICTS THE FIRST STATEMENT ABOUT USING AN INCORRECT DEVICE AS DESCRIBED IN B5 OF MDR REPORT REFERENCE NUMBER 0500170000-2023-8001. THE TWO MEDICAL DEVICES DESCRIBED BY THE USER FACILITY AS "LOOKING ALMOST IDENTICAL" ARE VISUALLY DIFFERENT FROM EACH OTHER, AND HAVE THEIR OWN INTENDED USE, WARNINGS AND INSTRUCTIONS FOR USE (IFU). KIT #AV-100HV - INSTRUCTIONS FOR USE STATES TO BE USED WITH PATIENT ON VENTILATOR. THIS LABEL IS PLACED ON KIT PACKAGING IN LARGE GREEN PRINT, AND IN TWO LOCATIONS OF THE PACKING INSERT. KIT #AV-100H - INSTRUCTIONS FOR USE STATES NOT TO BE USED WITH A PATIENT ON A VENTILATOR. THIS WARNING IS PLACED ON KIT PACKAGING IN LARGE BLUE PRINT, IN TWO LOCATIONS OF THE PACKING INSERT, AND ON THE KIT ITSELF NEAR THE MOUTH PORT OPENING BEFORE PLACING INTO THE PATIENT'S MOUTH FOR USE. FOR KIT COMPARISON, REFER TO EXHIBITIONS A AND B. THE MEDICAL DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE ISSUE DESCRIBED IN THE REPORT CANNOT BE DUPLICATED AS IT APPEARS TO HAVE BEEN USER ERROR. CONCLUSION: MEDI/NUCLEAR CORPORATION, INC. CONSIDERS THIS MDR REPORT TO BE AN UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO FAILING TO FOLLOW THE INSTRUCTIONS IN THE (IFU) INSTRUCTIONS FOR USE AND WARNINGS IN THE MEDICAL DEVICE AND INSTRUCTIONS FOR USE. THIS REPORTED PROBLEM BY THE USER FACILITY, CANNOT BE REPRODUCED DURING INVESTIGATION. THIS REPORT WILL BE FILED AS A CUSTOMER COMPLAINT WITH NO CORRECTIVE ACTION NEEDED.

    Description of Event or Problem · 0

    MANUFACTURER: MEDI/NUCLEAR CORPORATION INC. STATEMENT: THIS MDR REPORT IS IN REFERENCE NUMBER 0500170000-2023-8001. THE REPORTED PROBLEM FROM THE USER FACILITY STATES THAT THE DEVICE AV-100HV WAS USED WITH A VENTILATED PATIENT. THIS IS THE CORRECT DEVICE TO USE WITH A VENTILATED PATIENT, SO THIS STATEMENT CONTRADICTS THE FIRST STATEMENT ABOUT USING AN INCORRECT DEVICE AS DESCRIBED IN B5 OF MDR REPORT REFERENCE NUMBER 0500170000-2023-8001. THE TWO MEDICAL DEVICES DESCRIBED BY THE USER FACILITY AS "LOOKING ALMOST IDENTICAL" ARE VISUALLY DIFFERENT FROM EACH OTHER, AND HAVE THEIR OWN INTENDED USE, WARNINGS AND INSTRUCTIONS FOR USE (IFU). KIT #AV-100HV - INSTRUCTIONS FOR USE STATES TO BE USED WITH PATIENT ON VENTILATOR. THIS LABEL IS PLACED ON KIT PACKAGING IN LARGE GREEN PRINT, AND IN TWO LOCATIONS OF THE PACKING INSERT. KIT #AV-100H - INSTRUCTIONS FOR USE STATES NOT TO BE USED WITH A PATIENT ON A VENTILATOR. THIS WARNING IS PLACED ON KIT PACKAGING IN LARGE BLUE PRINT, IN TWO LOCATIONS OF THE PACKING INSERT, AND ON THE KIT ITSELF NEAR THE MOUTH PORT OPENING BEFORE PLACING INTO THE PATIENT'S MOUTH FOR USE. FOR KIT COMPARISON, REFER TO EXHIBITIONS A AND B. THE MEDICAL DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE ISSUE DESCRIBED IN THE REPORT CANNOT BE DUPLICATED AS IT APPEARS TO HAVE BEEN USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435061 AERO/VENT JR. AERO/VENT JR. VENTILATOR KIT W/HEPA FILTER, FOR VENTILATOR DEPENDENT PATIENTS IYT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown