MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Catalog Number TD 300/A

Device Problems Melted (1385); Material Twisted/Bent (2981)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

Two home patients home units that have bent prongs in the charging ports.One patient¿s home charging cord is damaged and looks as if it¿s disintegrating/melting around the prongs.The other cord is a loaner from cardio-thoracic intensive care unit (cticu) and shows the same kind of damage around the prongs, though to a lesser.

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNITED THERAPEUTICS; 1040 spring st.; silver spring MD 20910
• MDR Report Key: 15493559
• MDR Text Key: 300664711
• Report Number: 15493559
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: TD 300/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2022
• Event Location: Home
• Date Report to Manufacturer: 09/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1