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

Model Number ON-100HPA

Device Problems Device Emits Odor (1425); Battery Problem (2885)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A report was received through the us specialty pharmacy that a battery smelled bad.The battery was in a garage for two weeks and was smelling up the house and was noted to still smell bad.Consumer.Functional testing determined that battery pack sn (b)(4) did not meet product specifications, in that, battery pack will not hold sufficient charge to deliver minimum required amount of inhalations.The suspect odor was attributed to circuit relay overheating.Device manufacture date: 07/2010.

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): UT GMBH; eisenfeld 6382 0; GM 63820
• MDR Report Key: 4148304
• MDR Text Key: 18066415
• Report Number: MW5038457
• 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

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ON-100HPA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TYVASO
• Patient Outcome(s): Other