Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED THERAPEUTICS TYVASO INHALATION SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNITED THERAPEUTICS TYVASO INHALATION SYSTEM Back to Search Results
Model Number ON-100HPA
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Case description: this case is a spontaneous report from the united states received from a consumer via a specialty pharmacy on (b)(6) 2014.The pt is a (b)(6) female of an unreported height and race, who first received tyvaso (treprostinil) via inhalation on (b)(6) 2010 for primary pulmonary hypertension.Inhaled (ih) treprostinil dosage was 18 ti 54 mcg (3 to 9 breaths) four times daily at the time of the event.No relevant medical history or concomitant medications were reported.The pt reported the battery end had burned and would not hook to the back of the pump.The battery smelled burnt.The pt is not sure how it happened and thinks that it may have touched silverware on the table.The pump works as intended with the ac wall adapter.A new battery was sent to the pt.No adverse event reported as a result of the potential product malfunction.Initial reporter: consumer name/address withheld.(b)(4).Usage of device: initial use of device.The investigation is incomplete at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TYVASO INHALATION SYSTEM
Type of Device
INHALATION SYSTEM
Manufacturer (Section D)
UNITED THERAPEUTICS
MDR Report Key4643235
MDR Text Key16172862
Report NumberMW5041653
Device Sequence Number1
Product Code CAF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 12/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberON-100HPA
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TYVASO (TREPROSTINIL SODIUM) INHALATION GAS,; 0.6 MG/ML (B)(6) 2010 TO UNK
Patient Age54 YR
Patient Weight110
-
-