MAUDE Adverse Event Report: UNITED THERAPEUTICS INHALATION SYSTEM

Model Number TD-100

Device Problem Charging Problem (2892)

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

Event Type  malfunction  

Event Description

Per pt - one of her rechargeable batteries is not charging after she charges it using the wall plug or adapter.Will replace out this battery with a new one.No a/e experienced by patient during this malfunction.No further information known.

• Brand Name: INHALATION SYSTEM
• Type of Device: INHALATION SYSTEM
• Manufacturer (Section D): UNITED THERAPEUTICS; 1040 spring st.; silver spring MD 20910
• MDR Report Key: 6740073
• MDR Text Key: 81045158
• Report Number: MW5071214
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TD-100
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1