BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC PLUS VENTILATOR KIT W/ INTERNAL PEEP & CPAP

    MDR report key: 23226841 · Received October 6, 2025

    Report

    Report Number
    3012307300-2025-11263
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 6, 2025
    Manufacturer
    SMITH¿S MEDICAL INTERNATIONAL
    Product Code
    BTL
    PMA / PMN Number
    K123957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INCORRECTLY REPORTED UNDER MRN# 3012542015-2025-00006-00 ON 27-JAN-2025. H3: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE SERVICE HISTORY OF THIS DEVICE SHOWED NO PREVIOUS REPAIRS. THE CUSTOMER ISSUE WAS CONFIRMED VIA THE PERFORMANCE VERIFICATION TEST DURING AN ALARM SYSTEMS CHECK. THE DEVICE FAILED TO CONNECT ALARM TEST 5.2.3.4. THE ROOT CAUSE OF THE ISSUE WAS A DEFECTIVE INPUT MANIFOLD. THE MANIFOLD WAS REPLACED, AND THE DEVICE THEN PASSED ALL TESTS THEREAFTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT DID NOT CYCLE BREATHS AND HAD ALARM ISSUES. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226907 PNEUPAC PARAPAC PLUS VENTILATOR KIT W/ INTERNAL PEEP & CPAP VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITH¿S MEDICAL INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown