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

Lot Number 678G8000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Mdo reported the patient stepped on the cord between the altera nebulizer and the handset and needs a new cord.Unknown if patient missed a dose; no ade reported; unknown if device available for return.No further information known.Altera handset and nebulizer used to inhale cayston at above dose and frequency.Reported to (b)(6) by health professional.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 12467176
• MDR Text Key: 271534834
• Report Number: MW5103899
• 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: 06/07/2021

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
• Device Expiration Date: 12/31/2022
• Device Lot Number: 678G8000
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1