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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON HEALTHCARE, INC. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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OMRON HEALTHCARE, INC. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number BP7100
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 11/02/2020
Event Type  malfunction  
Event Description
When validating the home blood pressure monitor, discovered cuff was reading inaccurate and gave a false elevated reading.
 
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Brand NameOMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
OMRON HEALTHCARE, INC.
1925 west field court, suite' 100
lake forest IL 60045
MDR Report Key11154034
MDR Text Key226241761
Report Number11154034
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 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBP7100
Device Catalogue NumberBP7100
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2020
Event Location Hospital
Date Report to Manufacturer01/12/2021
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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