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

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Indication - cystic fibrosis, unspecified cystic fibrosis with pulmonary manifestations.Pseudomonas (aeruginosa), male (pseudomale) as the cause of disease classified elsewhere pt also stated that she needs a replacement altera device because the one she has is not working.Details are unk this prior to (b)(6) servicing pt.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: 9729047
• MDR Text Key: 180633392
• Report Number: MW5093085
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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