MAUDE Adverse Event Report: ACCUVEIN, INC. AV400; DEVICE, VEIN LOCATION, LIQUID CRYSTAL

Model Number AV 400

Device Problem No Display/Image (1183)

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

Event Date 07/11/2018

Event Type  malfunction  

Event Description

This was a malfunction of the accuvein device where the screen had only showed a partial display.We have seen these issues in the past, but the return and replace policy of accuvein has allowed for timely resolution to issues.

• Brand Name: AV400
• Type of Device: DEVICE, VEIN LOCATION, LIQUID CRYSTAL
• Manufacturer (Section D): ACCUVEIN, INC.; 40 goose hill road; cold spring harbor NY 11724
• MDR Report Key: 7713508
• MDR Text Key: 114837950
• Report Number: 7713508
• Device Sequence Number: 1
• Product Code: KZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AV 400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1