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

Device Problems Break (1069); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous.Patient reported that her old nebulizer machine broke and stopped working.Altera handset dose/route of administration/frequency: use as directed (for use with cayston: reconstitute with provided diluent and inhale the contents of 1 vial via pari altera nebulizer 3 times a day for 28 days on and 28 days off).Unk if patient missed any doses or had any adverse effects as a result.No lot number on record for device and expiration date was recorded as of 12/31/2023.Unknown if patient still has defective device on hand for return.No further information.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 17070611
• MDR Text Key: 316668481
• Report Number: MW5118160
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female