BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUPAC PARAPAC PLUS

    MDR report key: 19128767 · Received April 17, 2024

    Report

    Report Number
    3012307300-2024-02692
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    March 3, 2024
    Report Date
    May 20, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    UDI-DI
    35019315107263
    PMA / PMN Number
    K123957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RECEIVED FOR INVESTIGATION. THEREFORE, WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF WE RECEIVE THE DEVICE, WE WILL REOPEN THE INVESTIGAITON FOR FURTHER EVALUATION. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT INFORMATION: ELMER DIWA/RT SUPERVISOR / [email protected] / +1(626)-821-2372. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. 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 THAT THE VENTILATOR WAS BEING SET-UP FOR A PATIENT BEING TRANSFERRED TO CT, AND THE VENTILATOR STARTED ALARMING, AND WHEN CHECKED IT WAS DELIVERING PROLONG BREATH WITHOUT EXHALATION. THE PATIENT WAS IMMEDIATELY TAKEN OFF THE VENTILATOR AND OUT BACK ON A SERVO I VENTILATOR. THE PATIENT SUFFERED PNEUMOTHORAX AND THE DOCTOR HAD TO INSERT CHEST TUBE. THE CUSTOMER HAS REPORTED THE EVENT TO THE BOARD OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913942 PNEUPAC PARAPAC PLUS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC. 35019315107263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention