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OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR
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| Model Number BP742N |
| Device Problem
Low Readings (2460)
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| Patient Problems
Blurred Vision (2137); Dizziness (2194)
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| Event Date 04/26/2021 |
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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Consumer sent following information: my wife has been using this unit and recently we found out that the reading of the monitor is not accurate in the hard way.My wife is pregnant and recently my wife was admitted to at (b)(6) medical center hospital because her bp was at 200/140.She was not feeling very well when we checked her bp and home bp monitor (omron advance accuracy unit) it was showing 141/70.She has been in the hospital since (b)(6) 2021 due to the bp was so high.I am the husband and i took the home monitor to the hospital and told the nurse to check side by side with their hospital machine and our home monitor the difference was significant.I am writing to you that i believe this unit has a default in the system.Depending on this system has caused a significant damage to my wife's health and with excessive hospital bills for us.Also at the moment our unborn baby's life in danger because we could not use the bp monitor to catch it before it went so high.I would like your attention on this, help me with replacing a better accurate functional unit, and please help compensate with this exorbitant hospital bills on the way.We specifically bought his unit because it says that it is the #1 doctor recommended but at the hospital the doctor herself was surprised.This has been a life and a death situation experience for us.No only one life it could have affected my wife and the baby.During follow-up with omron representative, 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 29 weeks pregnant when entered in the hospital and still hospitalized at week 32 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 another 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.Consumer called back and quality representative requested additional details.According to consumer, when his wife was admitted to hospital, they treated her for hypertension so gave her iv and magnesium sulfate and they kept measuring blood pressure and vital signs every four hours.She has two healthy kids that were delivered full term.She was diagnosed with hypertension after second child turned two years old and then was on put on bp medication.She was on hydrochlorothiazide 25 mg during this pregnancy.Her doctor advised that it was best to deliver baby early so baby was delivered on (b)(6) 2021.The baby is nicu but the baby and mom are doing better.Her blood pressure has gone down since delivery and ranges between 125 to 145 and she has been put her on another bp medication.Consumer stated he knows that the blood pressure monitor did not cause her to have hypertension but wishes they had known earlier her bp was high.Consumer confirmed that he is going to send the unit back when he goes home and receives the replacement unit.
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Event Description
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Consumer sent following information: my wife has been using this unit and recently we found out that the reading of the monitor is not accurate in the hard way.My wife is pregnant and recently my wife was admitted to at chandler regional medical center hospital because her bp was at 200/140.She was not feeling very well when we checked her bp and home bp monitor (omron advance accuracy unit) it was showing 141/70.She has been in the hospital since (b)(6), 2021 due to the bp was so high.I am the husband and i took the home monitor to the hospital and told the nurse to check side by side with their hospital machine and our home monitor the difference was significant.I am writing to you that i believe this unit has a default in the system.Depending on this system has caused a significant damage to my wife's health and with excessive hospital bills for us.Also at the moment our unborn baby's life in danger because we could not use the bp monitor to catch it before it went so high.I would like your attention on this, help me with replacing a better accurate functional unit, and please help compensate with this exorbitant hospital bills on the way.We specifically bought his unit because it says that it is the #1 doctor recommended but at the hospital the doctor herself was surprised.This has been a life and a death situation experience for us.No only one life it could have affected my wife and the baby.During follow-up with omron representative, 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 29 weeks pregnant when entered in the hospital and still hospitalized at week 32 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 another 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.Consumer called back and quality representative requested additional details.According to consumer, when his wife was admitted to hospital, they treated her for hypertension so gave her iv and magnesium sulfate and they kept measuring blood pressure and vital signs every four hours.She has two healthy kids that were delivered full term.She was diagnosed with hypertension after second child turned two years old and then was on put on bp medication.She was on hydrochlorothiazide 25 mg during this pregnancy.Her doctor advised that it was best to deliver baby early so baby was delivered on (b)(6), 2021.The baby is in nicu but the baby and mom are doing better.Her blood pressure has gone down since delivery and ranges between 125 to 145 and she has been put her on another bp medication.Consumer stated he knows that the blood pressure monitor did not cause her to have hypertension but wishes they had known earlier her bp was high.Consumer confirmed that he is going to send the unit back when he goes home and receives the replacement unit.
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Manufacturer Narrative
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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.Updated information section d9.Additional information added to section h10.After initial report was submitted, consumer returned the unit back to importer for evaluation.The importer evaluated the returned unit and it passed evaluation.Then, the returned unit was sent to device manufacturer for further testing.Here is the summary of the manufacturer device investigation: the unit was tested and unit was working within specifications.Therefore, the consumer returned product was judged a conforming product.Further investigation in to cause was considered since the consumer had stated the unit was reading lower than the doctor's unit was by 20 mm hg.The number of bp measurements recorded on the main unit was 221 times.The measurement records were 50 times for each of users 1 and 2.The manufacturer reviewed bp measurements stored on the unit but was not able to confirm the cause of difference in readings at the hospital and reading obtained using omron unit.Since the measuring equipment, measuring method and person taking bp at the hospital are unknown, it is not possible to assume or find the cause.The manufacturer reviewed the qa test data, post market data/complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.No issue or no increasing trend was noted for complaint data review.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.Since there was no issue found with returned device; further investigation and correction is not necessary.
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