MAUDE Adverse Event Report: UT GMBH TYVASO INHALATION SYSTEM; NEBULIZER

Model Number ON-100/7

Device Problem Smoking (1585)

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

Event Type  malfunction  

Event Description

This case is a report from the united states regarding a report received from a consumer regarding a (b)(6)-year-old female who first received tyvaso (treprostinil) on (b)(6) 2011 for primary pulmonary hypertension.Inhaled treprostinil dosage was 18 to 54 micrograms (mcg) (three to nine breaths), four times daily at the time of the event.On an unspecified date, the patient was connected to a battery for treatment, then the unit started to smoke at the battery connection to the optineb.The patient noted that "it smelled electrical." the same battery was used and the patient completed her treatment with her other pump.The optineb device was replaced.Consumer.Device manufacture date: 10/2010.(b)(4).

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): UT GMBH; eisenfeld 6382 0; GM 63820
• MDR Report Key: 4148266
• MDR Text Key: 4930161
• Report Number: MW5038456
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ON-100/7
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TYVASO
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 60