MAUDE Adverse Event Report: VERIDIAN HEALTHCARE, LLC GOOD NEIGHBOR PHARMACY BLOOD PRESSURE MONITOR, ARM AUTO CUFF; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number 90-553

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

Device was reading several mmhg higher than actual blood pressure.

• Brand Name: GOOD NEIGHBOR PHARMACY BLOOD PRESSURE MONITOR, ARM AUTO CUFF
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): VERIDIAN HEALTHCARE, LLC; 1175 lakeside drive; gurnee IL 60031
• MDR Report Key: 11723307
• MDR Text Key: 247219210
• Report Number: 11723307
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 90-553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2021
• Date Report to Manufacturer: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1