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

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Per mom, (b)(6) - they run the nebulizer for it's 5 min cycle, but there is still a little medication left over, so they run it for another min or so, for a total of 6.5 min each time they use the nebulizer.Mom believes the handset stops working properly towards the end of the cycle.No further info cayston inh soln - inhale the contents of 1 vials (75 mg) via pari altera nebulizer 3 times a day for 28 days on and 28 days off.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 12638942
• MDR Text Key: 277118740
• Report Number: MW5104652
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• 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: 05/19/2021

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 Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1