MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA HANDSET (NO COST); NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Fibrosis (3167)

Event Type  malfunction  

Event Description

Spontaneous.(b)(6), respiratory therapist, reported that current compressor does not work, and so they are calling in order for new replacement machine.The dates and details of the defective device event were not reported.No missed doses or adverse events were reported as a result.Unknown if defective device is still on hand for return or not.The lot number was not reported and not found in pharmacy records.No further information.Indication: cystic fibrosis with pulmonary manifestations; dose/frequency route of administration: to use as directed to administer cayston [via nebulizer).Reported to (b)(6) by health professional.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 16868435
• MDR Text Key: 314627772
• Report Number: MW5117232
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male