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

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

Pt reports via secure message "i received the pari altera nebulizer handset and the ebase controller kit.I am missing 2 of the 3 handsets and the power cord to the ebase controller.I must, as the cayston instructions state, take three treatments per day, and after each treatment, i must clean the handset and let it air dry.I need a total of 3 handsets.Also, the ebase did not come with a power cord, like the paperwork that came in the controller kit box said that it would.It stops mid-treatment, despite using brand new batteries." no side effects reported.Unk if prescriber aware.Patient has defective product for return.Indication: cystic fibrosis, unspecified.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: 12834954
• MDR Text Key: 281080191
• Report Number: MW5105403
• 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: 11/12/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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