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

Lot Number 9896259

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Pt's mom reported gray cord to altera device is broken on one end and needs a new one.Unknown if pt missed any doses due to issue.Unknown if pt suffered an adverse event.Unknown if device is available for return.Unknown if specialist aware.No further information known.Dose/frequency for cayston: reconstitute with provided diluent and inhale the contents of l vial via pari altera nebulizer 3 times a day for 28 days on and 28 days off.Indication: chronic respiratory failure, unspecified whether with hypoxia or hypercapnia.Reported to (b)(6) by: patient/caregiver.

• Brand Name: ALTERA HANDET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 17315697
• MDR Text Key: 319046100
• Report Number: MW5119313
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 9896259
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male