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

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Spontaneous: patient's wife reported that the patient's altera nebulizer machine is broken and they were unable to use the last shipment of cayston that was delivered on 09/13/2022 unknown specifics of how the machine is broken.Unknown how many doses were missed; no adverse event reported from missed doses.No additional information was reported.Frequency: 3 times a day for 28 days on and 28 days off.Unknown if product fault occurred in use with patient.Unknown if fault caused/contributed to patient injury.Unknown if there was any subsequent medical intervention.Unknown if product is available for investigation.Product has not yet been replaced; cvs contacted the manufacturer to see if device can be replaced.Unknown if patient had back up device.Reported to cvs/caremark by pt/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 15658850
• MDR Text Key: 302399772
• Report Number: MW5112790
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAYSTON
• Patient Sex: Male