MAUDE Adverse Event Report: TYVASO INHALATION SYSTEM; NEBULIZER

Model Number TD-100/A

Device Problem Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Device (td-100) is functional but patient stated the device's charger not holding a charge.Patient did not have device with him to provide serial number.No ade's were reported from this issue.No further information known.Follow up phone call to patient, could not obtain serial number.Reason for use: pah.

• Brand Name: TYVASO INHALATION SYSTEM
• Type of Device: NEBULIZER
• MDR Report Key: 7048527
• MDR Text Key: 92654426
• Report Number: MW5073451
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TD-100/A
• Other Device ID Number: C0000303679
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NAME: TYVASO, STRENGTH: 0.6 MG, MANUFACTURER: UNITED THERAPEUTICS. DOSE OR AMOUNT: 9 BREATHS, FREQUENCY: 4 TIMES DAILY, ROUTE: INHALED.