BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 15445578 · Received September 19, 2022

    Report

    Report Number
    3012307300-2022-19607
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    February 12, 2020
    Report Date
    September 19, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BXR
    UDI-DI
    10788942560604
    PMA / PMN Number
    K873498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. NO PROBLEM WAS FOUND. ROOT CAUSE CANNOT BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED DUE TO THE FACT THE SAMPLE WAS TESTED AND SUCCESSFULLY PASSED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FUNCTIONAL TESTE FAILED. AFTER TESTING WITH POSITIVE AND NEGATIVE PRESSURE USING A SMALL SYRINGE, THE GAUGE POINTER CANNOT RETURN TO ZERO AND STOPS AT JUST OUTSIDE THE EDGE OF THE BLACK SQUARE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522886 PORTEX METER, AIRWAY PRESSURE (INSPIRATORY FORCE) BXR SMITHS MEDICAL ASD, INC. 55-6060 3898024 10788942560604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown