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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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NOVA SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 03/18/2021
Event Type  malfunction  
Event Description
Caller reports that she and her husband have been getting high readings from the blood pressure monitor ranging from 180-90, 190/90, and 200/90. With the use of the blood pressure monitor provided at the doctors office the readings were 130/62 and 130/70 within normal limits.
 
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Brand NameNOVA
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
MDR Report Key11553207
MDR Text Key242164248
Report NumberMW5100183
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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