BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC PLUS

    MDR report key: 18547997 · Received January 19, 2024

    Report

    Report Number
    2183161-2024-00078
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 1, 2023
    Report Date
    May 20, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    UDI-DI
    35019315107263
    PMA / PMN Number
    K123957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT AND D5. OPERATOR OF DEVICE IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. 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.

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THIS FILE, IT WAS FOUND TO BE A DUPLICATE OF AN EXISTING FILE. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH MRN 2183161-2024-00078. ALL REPORTS RELATED TO THIS EVENT WILL BE FILED UNDER MRN: 2183161-2024-00204.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS PHYSICALLY DAMAGED. PATIENT INVOLVEMENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401509 PNEUPAC PARAPAC PLUS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC. 35019315107263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown