• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR Back to Search Results
Model Number BP742N
Device Problem Low Readings (2460)
Patient Problems Blurred Vision (2137); Dizziness (2194)
Event Date 04/26/2021
Event Type  Injury  
Manufacturer Narrative
A root cause has not been determined. It has not been confirmed if the device caused or contributed to the reported incident. However, due to the customer reporting having dizziness and blurred vision and hospitalization this medwatch is being filed. The product instruction manual includes following warnings: this device is not intended to be a diagnostic device. Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases. The u. S importer is requesting the manufacturer of the device to further investigate this incident.
 
Event Description
Consumer reported that his pregnant wife took blood pressure reading and it was 140/74 mmhg and normal for her is 130/75 mmhg. She was not feeling well; she was dizzy and her eyes were getting blurry. They called ob-gyn and were told to go to hospital. Her reading was 200/140 mm/hg at the hospital. His wife is taking high blood pressure medication. She was (b)(6) pregnant when entered in the hospital and still hospitalized at (b)(6) to stabilize and keep her blood pressure at 140. His wife had been measuring her blood pressure three times a day and was always in same range. This was the first time she had symptoms with a normal blood pressure reading. Her arm size is average. She is in the hospital and not available for arm size measurement. She was taking bp readings at dining room table, sitting up straight. She was using her left arm for measurement. If the unit was reading a little high then she would take second reading on left arm about 5 minutes later. There was usually just a 2 to 3 mmhg difference between two readings. She applied the cuff snug, and there was no pain when taking bp readings. She was admitted to hospital and still there 3 weeks later and may be there longer. During a follow-up call, consumer stated unit was reading higher than what his wife's normal blood pressure was, but the reading was lower than what the hospital reading was. Her bp reading using the home unit was 140/75, but his wife was not feeling well. She was dizzy and her vision was going blurry so he took her to the hospital. Her bp was 200/140 at the hospital. She is still in the hospital three weeks later. Her blood pressure keeps fluctuating so they have been keeping her to monitor her and the baby. The cuff is original that came with unit and his wife used it three times a day. He did take the unit to do a comparison with the doctor's unit. The unit was reading lower than doctor's unit. The reading was about 20 mmhg lower, but he does not remember the exact numbers. Consumer would like the unit to be replaced with new unit. Omron customer service representative advised consumer stop using the unit. Consumer was sent a postage paid label to retrieve the unit back for testing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMRON 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR
Type of DeviceBLOOD PRESSURE MONITOR
Manufacturer (Section D)
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
no. 28 vsip ii, st. 2,
vietnam-singapore indus. park
hoa phu thu dau mot city, 82000 0
VM 820000
MDR Report Key11898158
MDR Text Key266663859
Report Number1450057-2021-00006
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBP742N
Device Catalogue NumberBP742N
Device Lot Number201604VG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2021
Distributor Facility Aware Date05/21/2021
Device Age5 YR
Event Location Home
Date Report to Manufacturer05/27/2021
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

Patient Treatment Data
Date Received: 05/27/2021 Patient Sequence Number: 1
-
-