BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC VENTILATOR MEDIC MODEL

    MDR report key: 19934475 · Received August 7, 2024

    Report

    Report Number
    3012307300-2024-07325
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 16, 2024
    Report Date
    November 21, 2024
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    BTL
    UDI-DI
    10610586045486
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - PRIMARY UDI NUMBER: CORRECTED. D9: DATE RETURNED TO MFG.: UNKNOWN. H3 AND H6. CODES: UPDATED. ONE DEVICE WAS RECEIVED FOR EVALUATION. ALL EXTERNAL CONNECTIONS WERE CHECKED AND ARE TIGHT. A RUSH OF AIR WAS FELT FROM THE FRONT DIAL. THIS WAS VERIFIED DURING INSPECTION. THE DEMAND VALVE ASSEMBLY WAS CONTRIBUTING TO THE ISSUE. DUE TO OBSOLESCENCE AND LACK OF SPARE PARTS WE ARE UNABLE TO COMPLETE THE SERVICE OF THE VENTILATOR. THE DEVICE WILL BE SENT BACK UN-REPAIRED OR SCRAPPED ON SITE PENDING CUSTOMER RESPONSE. 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

    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 DURING PRE-CHECKOUT THE MRI VENT HAS A LOUD LEAK WHEN TURNED ON, WHICH SOUNDED INTERNAL. ALL EXTERNAL CONNECTIONS WERE CHECKED AND WERE TIGHT. A RUSH OF AIR WAS FELT FROM THE FRONT DIAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066353 PNEUPAC PARAPAC VENTILATOR MEDIC MODEL VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL MD, INC. 10610586045486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown