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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 High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  malfunction  
Event Description
Device is reading >10mmhg higher than blood pressure checked against hospital monitor. Device taken out of service and new device given to patient.
 
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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 Key11705871
MDR Text Key246683429
Report Number11705871
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 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2021
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2021
Event Location Hospital
Date Report to Manufacturer04/22/2021
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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