MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM

Model Number TD100

Device Problems No Display/Image (1183); Device Emits Odor (1425); Smoking (1585)

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

Event Type  malfunction  

Event Description

This case is a spontaneous report from united states of america received from a consumer via a speciality pharmacy.The patient was a (b)(6)-year-old female who first received tyvaso (treprostinil) on (b)(6) 2013 for chronic pulmonary heart disease.Inhaled (ih) treprostinil dosage was 54 micrograms (9 breaths), four times daily at the time of the event relevant medical history and concomitant medications were not reported.On an unspecified date in 2014, the patient reported that she tried her car adapter and it worked for first three breaths.Then the screen went blank, and the adapter started smoking.She reported that the wiring gave burning smell with car charger.Device model number was reported as td100.The outcome of the event device malfunction unknown.Manufacturer report number (b)(4).

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: TYVASO INHALATION SYSTEM
• Manufacturer (Section D): UNITED THERAPEUTICS
• MDR Report Key: 4217261
• MDR Text Key: 4995643
• Report Number: MW5038880
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TD100
• Patient Sequence Number: 1
• Treatment: TYVASO (TREPROSTINIL SODIUM) INHALATION GAS,; 0.6MG/ML
• Patient Age: 71 YR
• Patient Weight: 77