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

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Indication - cystic fibrosis, unspecified and cystic fibrosis.Outbound call to (b)(6) spoke with "(b)(6)" let him know we are still having issues trying to get pt altera replacement as the altera handset is no longer functioning (details unk).He is going to reach out to pt for (b)(6) and then will notify us on how to proceed.Solicited call - no further info provided.Frequency - three times a day every other month.No lot number known, unk if pt still has product.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9525281
• MDR Text Key: 173068137
• Report Number: MW5091906
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 9994000628
• UDI-Public: 9994000628
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1