MAUDE Adverse Event Report: ARROW TELEFLEX; NAVIGATIONAL SYSTEM FOR PICC

Model Number VPS G4

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/25/2018

Event Type  malfunction  

Event Description

While placing arrow teleflex picc, the vps system failed.The doppler stopped and an error message appeared - "unrecoverable error dam error shutdown.".

• Brand Name: TELEFLEX
• Type of Device: NAVIGATIONAL SYSTEM FOR PICC
• Manufacturer (Section D): ARROW
• MDR Report Key: 7380878
• MDR Text Key: 103953528
• Report Number: MW5076208
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VPS G4
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR