BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC PLUS

    MDR report key: 19751164 · Received July 16, 2024

    Report

    Report Number
    3012307300-2024-06168
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 7, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    PMA / PMN Number
    K123957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. 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

    H6 EVALUATION CODES UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION FOUND THAT THE DEVICE WAS RECEIVED WITH A BENT AND CRACKED FRONT PANEL, DAMAGED INPUT/OUTPUT SIDE LABEL AND INSTRUCTION LABEL, AND MISSING PATIENT OUTLET FITTING/PORT. THE REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED. THE PATIENT OUTLET FITTING WAS REMOVED FROM DEVICE. THE PATIENT OUTLET FITTING WAS REPLACED AND REINSTALLED. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXHALATION PORT WAS BROKEN. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508145 PNEUPAC PARAPAC PLUS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown