MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA NEBULIZER SYSTEM FOR CAYSTON; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Infusion or Flow Problem (2964); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

Reports altera nebulizer system for cayston will not run unless he holds the button down.

• Brand Name: ALTERA NEBULIZER SYSTEM FOR CAYSTON
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 17070721
• MDR Text Key: 316681749
• Report Number: MW5118167
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male