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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR
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OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR Back to Search Results
Model Number BP742N
Device Problems Unable to Obtain Readings (1516); Low Readings (2460)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 08/15/2022
Event Type  Injury  
Event Description
The consumer's wife sent a web message stating her and her husband have an omron blood pressure monitor.The monitor was reading the consumer's blood pressure inconsistently.He had a lot of fluctuations in his readings, but it was often very low (40/20).When the machine gave an error, they would assume the reading was low, and he would take his medication.He is quadriplegic and has a skinny arm according to the consumer's wife.The consumer was recently hospitalized due to infection and low blood pressure.They originally went to the doctor then his wife called 911 since the unit was showing an e error code and would not provide a reading.He was taken to the hospital then put in the intensive care unit (icu) for four days.His medication for midodrine was increased by his doctor.They were unsure how long they have been using the unit for and did not know how many times a day they use it.They both use the unit and use both arms while in bed or in a wheel chair.The consumer's arm size is 10".The cuff was applied so only one finger can be placed between the cuff and skin.His blood pressure ranged from 40/20 to 160/80.The unit would sometimes inflate over 200.
 
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 consumer having been hospitalized 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
The consumer's wife sent a web message stating her and her husband have an omron blood pressure monitor.The monitor was reading the consumer's blood pressure inconsistently.He had a lot of fluctuations in his readings, but it was often very low (40/20).When the machine gave an error, they would assume the reading was low, and he would take his medication.He is quadriplegic and has a skinny arm according to the consumer's wife.The consumer was recently hospitalized due to infection and low blood pressure.They originally went to the doctor then his wife called 911 since the unit was showing an e error code and would not provide a reading.He was taken to the hospital then put in the intensive care unit (icu) for four days.His medication for midodrine was increased by his doctor.They were unsure how long they have been using the unit for and did not know how many times a day they use it.They both use the unit and use both arms while in bed or in a wheel chair.The consumer's arm size is 10".The cuff was applied so only one finger can be placed between the cuff and skin.His blood pressure ranged from 40/20 to 160/80.The unit would sometimes inflate over 200.
 
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 consumer having been hospitalized 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, the 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.There was no record of bp measurement data in the memory of the unit.Further investigation in to cause was considered since the consumer had stated the unit was reading low.Using the returned unit and cuff and a sample unit and cuff, the blood pressure was measured according to the measurement method described in the instruction manual.The manufacturer testing included deflation test, leakage test, and accuracy test.There was no significant difference in the results when tested three times.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.No abnormal trend identified during complaint data review by manufacturer.Following important safety information/warning is included in the instruction manual included with the blood pressure monitor: do not adjust medication based on measurement results from this blood pressure monitor.Take medication as prescribed by your physician.Only a physician is qualified to diagnose and treat high blood pressure.This device is not intended to be a diagnostic device.Since there was no issue found with returned device; further investigation and correction is not necessary.
 
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Brand Name
5 SERIES UPPER ARM BLOOD PRESSURE MONITOR
Type of Device
BLOOD 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 Key15352428
MDR Text Key299272264
Report Number1450057-2022-00006
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 Other
Type of Report Initial,Followup
Report Date 09/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberBP742N
Device Catalogue NumberBP742N
Device Lot Number201409VG
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/02/2022
Distributor Facility Aware Date08/17/2022
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer09/02/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexMale
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