MAUDE Adverse Event Report: UNITED THERAPEUTICS CORPORATION TD300 AC WALL PLUG TYVASO INHALATION SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous call from patient who reports wall plug won't fit into serial number (b)(4) on td300 device.Product issue did not cause injury.Device is available for investigation.Device was replaced.Patient had backup device he was able to use.Medication is life sustaining.Outcome is resolved pending receipt of replacement devices.No other information available.Reported to (b)(6) by pt/caregiver.

• Brand Name: TD300 AC WALL PLUG TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNITED THERAPEUTICS CORPORATION ; 55 tw alexander dr. ; po box 14186; research triangle park NC 27709
• MDR Report Key: 11528156
• MDR Text Key: 241425342
• Report Number: MW5100105
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1