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

Lot Number 020749

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Anoxic brain damage, not elsewhere classified; personal history of sudden cardiac arrest; tracheostomy status; epilepsy, unspecified spontaneous: dad stated the nebulizer system, the part where the batteries go in, broke.Directed him to pari.Unknown if any doses have been missed or any side effects experienced.Unknown if prescriber is aware.Device is on hand for return for inspection.Reported to (b)(6) by: patient/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC
• MDR Report Key: 13252303
• MDR Text Key: 283955309
• Report Number: MW5106642
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2022
• Device Lot Number: 020749
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male