BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ACAPELLA VIBRATORY PEP RESPIRATORY THERAPY SYSTEM

    MDR report key: 19268301 · Received May 8, 2024

    Report

    Report Number
    3012307300-2024-03481
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 4, 2024
    Report Date
    July 1, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BWF
    UDI-DI
    10788942215313
    PMA / PMN Number
    " K181660"
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE RETURNED DEVICE WAS TESTED PER INTERNAL PROCEDURES FOR LOW AND HIGH FLOW AND FAILED. THE DEVICE WAS OPENED, AND IT WAS IDENTIFIED THAT THE ROCKER COMPONENT WAS NOT PLACED CORRECTLY. AFTER SETTING THE ROCKER PROPERLY THE DEVICE WAS TESTED AGAIN FOR LOW AND HIGH FLOW PER PROCEDURE AND FAILED. THE DEVICE IS IN GOOD CONDITION AND THERE ARE NO INDICATORS AS TO WHY THE DEVICE WOULD FAIL. THE COMPLAINT IS CONFIRMED. THE MANUFACTURING TEAM HAS BEEN MADE AWARE OF THE DEFECT THAT OCCURRED. CUSTOMER COMPLAINTS WERE REVIEWED FOR THE PAST TWO YEARS FOR OTHER OCCURRENCES OF THE DEFECT DESCRIBED. ONE OTHER COMPLAINT WAS IDENTIFIED WITH THE SAME FAILURE. ICU MEDICAL CONTINUES TO MONITOR AND TRACK ALL CUSTOMER COMPLAINTS AND ESCALATE AS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS NO VIBRATION. THE ACAPELLA IS BLOCKED WITH STRONG EXHALATION. THE PATIENT STATED THAT WHEN HE BLOWS INTO IT, THE AIR ESCAPES ON THE OTHER SIDE WITH SLIGHT RESISTANCE BUT WITHOUT VIBRATIONS. WHEN HE BLOWS TOO HARD, THE AIR FLOW IS BLOCKED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752472 PORTEX ACAPELLA VIBRATORY PEP RESPIRATORY THERAPY SYSTEM SPIROMETER, THERAPEUTIC (INCENTIVE) BWF SMITHS MEDICAL ASD, INC. 4435609 10788942215313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown