MAUDE Adverse Event Report: EKOS CORPORATION EKO SONIC EKOS CATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number	500-55118
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ekos catheter stopped working during therapy and machine shut down.Medication therapy still infusing.No harm to pt.Fda safety report id# (b)(4).

• Brand Name: EKO SONIC EKOS CATHETER
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION
• MDR Report Key: 9225320
• Report Number: MW5090584
• Device Sequence Number: 10794987
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 0100858593006141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 500-55118
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 164