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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Solicited: per (b)(6) (rn) pt needs the new device due to his old one not working.No add'l info provided.Reported to (b)(6) by health professional.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC
• MDR Report Key: 11278658
• MDR Text Key: 230472829
• Report Number: MW5099206
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Patient Sequence Number: 1