BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PNEUPAC VENTILATOR SUPPORT GAUGE

    MDR report key: 16827964 · Received April 27, 2023

    Report

    Report Number
    3012307300-2023-04686
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Report Date
    May 10, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BXR
    UDI-DI
    10788942560604
    PMA / PMN Number
    K873498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY EVALUATED, AND EVENT WAS CONFIRMED THAT THE BLACK INDICATOR NEEDLE ON THE GAUGE READS -7.5 CMH20. PER OUR MANUFACTURING PROCEDURES THE OPERATOR IS SUPPOSED TO 100% VISUALLY INSPECT THE GAUGE READS ZERO WITH 100%-INSPECT CONFIRMATION OF FUNCTIONALITY. THE INSTRUCTIONS FOR USE FOR THE PRODUCT STATE THE USER IS ALLOWED TO TAKE THE FACEPLATE OFF AND MOVE THE GAUGE TO "0" (ZERO) WITH A SCREWDRIVER. THE RETURNED PRODUCT WAS TESTED FOR FUNCTIONALITY AND ACCURACY USING A PRESSURE AND VACUUM TEST. THE FACEPLATE WAS REMOVED, THE GAUGE MOVED TO 0, AND THEN TESTED. THE PRODUCT MET SPECIFICATIONS; THEREFORE, THIS DEFECT CANNOT BE CONFIRMED. THE ROOT CAUSE IS ASSEMBLY ERROR. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. FOR ALL ENQUIRIES OR FOLLOW-UP QUESTIONS RELATED TO THE RECORD, DO NOT USE (B)(6). LOCATED IN SECTIONS G.1., PLEASE DIRECT THOSE TO THE FOLLOWING: (B)(6).

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B3: DATE OF EVENT, D4: LOT NUMBER, EXPIRATION DATE, AND H4: MANUFACTURE DATE ARE UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GAUGE DOES NOT READ CORRECTLY AND IS NOT SET FOR ZERO (0). PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045621 PORTEX PNEUPAC VENTILATOR SUPPORT GAUGE METER, AIRWAY, PRESSURE (INSPIRATORY FORCE) BXR SMITHS MEDICAL ASD, INC. 55-6060 10788942560604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown