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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous call from patient states that her altera is not working and was advised that since the device is still under warranty so she will need to call the manufacturer at (b)(4) to get free replacement.Patient called back (b)(6) 2021 and advised that she called manufacturer and they state they only replace parts not entire machine.No further information.No missed dose and no side effect was reported.Patient has device on hand for return for inspection.Indication: cystic fibrosis with pulmonary manifestations.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 12658791
• MDR Text Key: 277630936
• Report Number: MW5104711
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1