BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING

    MDR report key: 15444999 · Received September 19, 2022

    Report

    Report Number
    3012307300-2022-19572
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    March 10, 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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ONE UNIT WAS RECEIVED, NOT IN ITS ORIGINAL PACKAGE, THEREFORE THE LABELING OF THE BOX COULD NOT BE EVALUATED. THE UNIT RECEIVED IS THE CORRECT PART NUMBER SPECIFIED IN THE COMPLAINT. THE UNITS ARE 100% FUNCTIONAL TESTED AND VISUALLY INSPECTED PRIOR TO PACKAGING AND SHIPMENT. THE UNIT WAS TESTED PER INTERNAL TEST PROCEDURES AND MET ALL THE SPECIFICATIONS. THE GAUGE IS ACCURATE BOTH WAYS, PRESSURE AND VACUUM. THE RED INDICATOR NEEDLE FOR THIS PART NUMBER IS NOT INTENDED TO MOVE WITH THE BLACK NEEDLE WHEN UNDER PRESSURE. THERE WAS NO FAULT FOUND ON THIS DEVICE. NO CORRECTIVE ACTIONS ARE PLANNED AT THIS TIME. THE MANUFACTURE REGULARLY ANALYZES COMPLAINT DATA AND TRENDS AND WILL TAKE FURTHER ACTIONS ACCORDINGLY. OPERATOR OF DEVICE IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RED INDICATOR NEEDLE DOES NOT MOVE WITH THE BLACK NEEDLE WHEN UNDER PRESSURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372547 INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING METER, AIRWAY PRESSURE (INSPIRATORY FORCE) BXR SMITHS MEDICAL ASD, INC. 55-6060 3217021 10788942560604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown