BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUPAC VENTILATORS

    MDR report key: 13193202 · Received January 7, 2022

    Report

    Report Number
    3012307300-2022-00294
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    November 17, 2021
    Report Date
    June 20, 2023
    Manufacturer
    NULL
    Product Code
    CAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE WAS IN GOOD CONDITION. THE CUSTOMER STATED PROBLEM WAS DUPLICATED, CONTINUOUS FLOW IS PRESENT AND INTERMITTENT AT DETENT AND ADULT SETTINGS. REPLACED FAULTY TIMING VALVE ASSEMBLY. DURING INVESTIGATION WAS FOUND WEAR AND TEAR ON 15 YEAR OLD DEVICE THAT PROBABLY SUFFERED IMPACT DAMAGE (YELLOW CASE SEPARATION WAS FOUND). THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. THE PREVIOUS SERVICE HISTORY HAS BEEN REVIEWED AND DEEMED UNRELATED TO THE CURRENT CUSTOMER REPORTED REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RESCUE CREW REPORTED THAT WHEN IN AUTOMATIC MODE THE VENTILATIONS BECOME MORE PROLONGED.

    Description of Event or Problem · 0

    PER RO 1203042: THE RESCUE CREW REPORTED THAT WHEN IN AUTOMATIC MODE THE VENTILATIONS BECOME MORE PROLONGED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 03-JAN-2022: DATE OF EVENT UPDATED, ". IT WAS WITH A PATIENT AND WAS NOTICED RIGHT AWAY, WHERE THE CREW DISCONNECTED AND SWITCHED TO MANUAL VENTILATIONS VIA BVM. IT WAS ALSO RECHECKED AFTER THE CALL AND HAPPENED AGAIN WHEN NOT CONNECTED TO A PATIENT. NO ADVERSE EFFECTS WERE NOTED IN THE REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169469 PNEUPAC VENTILATORS BREATHING CIRCUIT CIRCULATOR CAG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention