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

Device Problems Break (1069); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Indication: cystic fibrosis with pulmonary manifestations.Inbound call from patient.Patient reported that the altera device cord is damaged - the plug had broken off of the cord and cannot be plugged in to the wall.Manufacturer was notified.Unknown if any adverse event or missed dose occurred.At time of call, patient still had defective device on hand.Unknown if md is aware.No further information reported.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: 12467278
• MDR Text Key: 271639051
• Report Number: MW5103907
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• 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