MAUDE Adverse Event Report: UNITED THERAPEUTICS CORPORATION, CORPORATE HEADQUARTERS TYVASO TD300 INH SYST IFU; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number TD300

Device Problems Failure to Power Up (1476); Defective Device (2588)

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

Event Type  malfunction  

Event Description

Received an unsolicited call to complete counseling for tyvaso, per the patient, td300 device serial number (b)(4) takes too long to turn on even when it is fully charged on plugged in.Pump takes too long to turn on, so not in use.No harm to the patient.Pump available for return.Lot number and expiration date not available.Reported to (b)(6) by pt/caregiver.

• Brand Name: TYVASO TD300 INH SYST IFU
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNITED THERAPEUTICS CORPORATION, CORPORATE HEADQUARTERS; 1040 spring st. ; silver spring MD 20910
• MDR Report Key: 12452579
• MDR Text Key: 271021162
• Report Number: MW5103814
• 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: 07/08/2021

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: No Information
• Device Model Number: TD300
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1