BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPEP PEP THERAPY SYSTEM

    MDR report key: 19355707 · Received May 20, 2024

    Report

    Report Number
    3012307300-2024-03969
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 1, 2024
    Report Date
    October 29, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BWF
    UDI-DI
    10788942200500
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. EXPIRATION DATE AND MANUFACTURE DATE ARE UNKNOWN, INVALID LOT NUMBER PROVIDED BY THE CUSTOMER 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

    D3. MANUFACTURING PLANT ADDRESS 1: (B)(6). D3. MANUFACTURING PLANT CITY: (B)(6). D3. MANUFACTURING PLANT STATE: (B)(6). D3. ZIP CODE: (B)(6). D4. SERIAL #: (B)(6). D4. PRIMARY UDI NUMBER: (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE 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 BY THE PATIENT THAT "THE MACHINE HAS NOT BEEN WORKING, AND HER CONDITION IS CRITICAL. UNABLE TO BREATHE WITHOUT THE MACHINE AND HAS SHORTNESS OF BREATH". ADDITIONAL ADVERSE PATIENT EFFECTS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569801 THERAPEP PEP THERAPY SYSTEM SPIROMETER, THERAPEUTIC (INCENTIVE) BWF SMITHS MEDICAL ASD, INC. 5598839 10788942200500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown