MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA HANDSET; NEBULIZER (DIRECT PATIENT INTERFACE)V

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Patient reported that device she received in (b)(6) is not currently working.She has tried to clean and it is still not working.Stated that it never worked correctly.She says she ordered medication way ahead of cycle and just started using the device (unknown start date of device).No missed dose or adverse events reported from defective device; unknown if available for return; unknown if md aware.No further information provided.Used to deliver cayston at above dose/frequency.Reported to (b)(6) by: patient/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)V
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 15916680
• MDR Text Key: 304921381
• Report Number: MW5113631
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female