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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WITHINGS S.A. BP CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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WITHINGS S.A. BP CONNECT 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 07/01/2021
Event Type  malfunction  
Event Description
Inaccurate bp classification. Reporting 119/80 as stage 1 and 121/80 as elevated. Wrong according to new guidelines. Fda safety report id# (b)(4).
 
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Brand NameBP CONNECT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
WITHINGS S.A.
MDR Report Key12159749
MDR Text Key261481578
Report NumberMW5102471
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 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2021
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 Answer provided
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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