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

Pt's mother, (b)(6), reported the nebulizer was working when the cayston was ordered, but it has stopped working.Lot number and expiration date are unk.Unk if pt experienced an adverse event due to the defective product.Spontaneous call.No add'l info.Indication cystic fibrosis.Unspecified, situs inversus, pneumonia due to pseudomonas.Other disorders of lung, and other specified congenital malformations of respiratory system.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: 9543879
• MDR Text Key: 173746370
• Report Number: MW5092017
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 9994000628
• UDI-Public: 9994000628
• Combination Product (y/n): N
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1