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

Device Problem Electrical Shorting (2926)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient reported that his power cord for his altera device has a short, and the product is not working correctly.Unknown if dose was missed due to faulty cord, or extent of product malfunction.This is used with patients cayston prescription.No further information to report expiration date 01/31/2023 reported is for device.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? unk; is the actual device available for investigation? unk; did we [mfr] replace the device? unk; did the pt have a backup device they were able to switch to? unk.Reported to (b)(6)/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: 13783219
• MDR Text Key: 287424126
• Report Number: MW5108188
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male