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U.S. Department of Health and Human Services

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

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VERIDIAN HEALTHCARE, LLC GOOD NEIGHBOR PHARMACY BLOOD PRESSURE MONITOR, ARM AUTO CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
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.
 
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Brand NameGOOD NEIGHBOR PHARMACY BLOOD PRESSURE MONITOR, ARM AUTO CUFF
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
VERIDIAN HEALTHCARE, LLC
1175 lakeside drive
gurnee IL 60031
MDR Report Key11723307
MDR Text Key247219210
Report Number11723307
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number90-553
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2021
Event Location No Information
Date Report to Manufacturer04/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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