BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC MEDIC MODEL

    MDR report key: 18547617 · Received January 19, 2024

    Report

    Report Number
    2183161-2024-00081
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 19, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT AND D4: UDI IS UNKNOWN. 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 THE FILE IT WAS DETERMINED THAT IS WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN 2183161-2024-00081 . PLEASE REFERENCE FILE MRN 2183161-2024-00100 FOR ALL DETAILS PERTINENT TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS STATED THAT IS NOT ALARMING/LIGHT INDICATORS NOT TURNING ON. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123297 PNEUPAC PARAPAC MEDIC MODEL VENTILATOR, EMERGENCY, POWERED (RES) BTL SMITHS MEDICAL ASD, INC. 120003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown