MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. NAVVUS; TRANSDUCER, PRESSURE, CATHETER TIP

Catalog Number 014667

Device Problem No Device Output (1435)

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

Event Date 05/06/2015

Event Type  malfunction  

Event Description

Flowwire did not register after being connected to a portable monitor.New flowwire was opened and worked.

• Brand Name: NAVVUS
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 4780763
• MDR Text Key: 17221115
• Report Number: 4780763
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/12/2015

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: Physician
• Device Catalogue Number: 014667
• Device Lot Number: ML00002631
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2015
• Patient Sequence Number: 1
• Patient Age: 66 YR