BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC ACCESSORIES

    MDR report key: 16036329 · Received December 22, 2022

    Report

    Report Number
    3012307300-2022-28132
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 1, 2022
    Report Date
    April 5, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. FUNCTIONAL TESTING FOUND DEVICE CAN'T CONNECT WITH OTHER COMPANY'S FEMALE COUPLER. IT WILL NOT BE LOCKED AND WILL COME OFF. THE DIMENSIONS OF THE MALE COUPLER OF THE COMPLAINED PRODUCT DO NOT CONFORM TO JIS STANDARDS. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE SUPPLIER ASSEMBLY FAULT. THE SUPPLIER MANUFACTURER HAS ALREADY IMPLEMENTED IMPROVEMENTS TO CHANGE THE SECONDARY MANUFACTURING SITE FOR FEMALE COUPLERS AFTER RECEIVING COMPLAINTS ABOUT THE SAME EVENT THAT OCCURRED IN 2017. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Additional Manufacturer Narrative · 0

    UDI AND DEVICE SERIAL NUMBER/LOT NUMBER ARE UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. A PRODUCT SAMPLE WAS RECEIVED AND IS AWAITING EVALUATION AND 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 CUSTOMER TRIED TO CONNECT THE HOSE TO THE COUPLER OF THE WALL PIPING, BUT COULD NOT DO IT PROPERLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614073 PNEUPAC ACCESSORIES VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown