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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Pt reported that altera device used to initiate cayston is not working properly (no specific details provided); this was the initial report to pharmacy.Lot number, expiration date, and pt identification number for program unk.Not specified if pt missed any doses or experienced an adverse event.Unk if the pt has the product on hand for return.Replacement has been scheduled, but has not shipped yet.Spontaneous cal, no add'l info available.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: 9799910
• MDR Text Key: 182565186
• Report Number: MW5093557
• 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: 02/19/2020

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: 03/05/2020
• Patient Sequence Number: 1