BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC

    MDR report key: 12081424 · Received June 28, 2021

    Report

    Report Number
    3012307300-2021-06610
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Report Date
    March 8, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTL
    UDI-DI
    35019315107263
    PMA / PMN Number
    K123957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE INTACT. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED FOR "VENT WILL NOT CYCLE" REPORTED PROBLEM , DEVICE CYCLED CONTINUOUSLY AS INTENDED AT VARIOUS SETTINGS AND IT WAS DUPLICATED FOR REPORTED PROBLEM "ALARM DO NOT FUNCTION". IT WAS FOUND A FAULTY ELECTRICAL CHASSIS ASSEMBLY WHICH WAS REPLACED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. NO PREVIOUS SERVICE HISTORY WAS FOUND. THE MANUFACTURING DHR IS NOT RELEVANT TO THE INVESTIGATION AS THE REPORTED FAULT WAS NOT FOUND.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS PARAPAC PLUS VENT WILL NOT CYCLE ON OR CYCLE OFF. WE HAVE HOOKED IT TO THE O2 SUPPLY SEVERAL TIME WITHOUT SUCCESS.DISCOVERED DURING BENCH TEST. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977419 PNEUPAC VENTILATOR BTL SMITHS MEDICAL INTERNATIONAL, LTD. P310NUS 35019315107263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown