MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. NEBULIZER PARI PLUS LC; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	PRP22F81
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Indication: chronic obstructive pulmonary disease, unspecified.Dose or amount: inhale the contents of 1 ampule of ohtuvayre (3mg/2.5ml) via nebulizer 2 times a day.Patient/patient's wife reported pari plus nebulizer lost air flow after 3months of use.They did not have any problems prior and tubing/everything else looks normal.Unk if patient experienced an adverse event.Unknown exact date of malfunction.Unknown if patient has product on hand for return to manufacturer.Reported to (b)(6) by pt/caregiver.

• Brand Name: NEBULIZER PARI PLUS LC
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 21124709
• Report Number: MW5164527
• Device Sequence Number: 14309046
• Product Code: CAF
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/26/2025
• Device Model Number: PRP22F81
• Device Lot Number: 240715
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OHTUVAYRE INH SUSP; VIOS LC AEROSOL DELIV SYST
• Patient Age: 66 YR
• Patient Sex: Male