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

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous call from patient reported her altera device wasn't working.Conference with (b)(6) access program.Patient described that the handset wasn't expelling the medication.He said it may be a handset issue.I dropped off the line so he could conference with (b)(6).I advised to have them callback in case we needed to order anything.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: 12664098
• MDR Text Key: 277677345
• Report Number: MW5104758
• 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: 07/27/2021

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