MAUDE Adverse Event Report: UNITED THERAPEUTICS CORPORATION TYVASO; INHALATION SYSTEM

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pt's husband reports that one of the batteries for the td-100 device does not hold it's charge.Serial number provided (b)(4).A replacement battery is being sent to the pt.Pt did not experience any ade as a result of the faulty battery.No other info known.Dose or amount: na.

• Brand Name: TYVASO
• Type of Device: INHALATION SYSTEM
• Manufacturer (Section D): UNITED THERAPEUTICS CORPORATION
• MDR Report Key: 7613310
• MDR Text Key: 111729709
• Report Number: MW5077913
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1