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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR

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OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR Back to Search Results
Model Number BP710N
Device Problem Inflation Problem (1310)
Patient Problems Bruise/Contusion (1754); Pain (1994)
Event Date 09/26/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). As of (b)(6) 2017, unit not returned for further investigation. The manufacturer reviewed the device history records, qa test data and risk analysis, complaint history for the model number and similar models and complaint records for similar issues. The shipping information was reviewed. No issue/problem was noted during data reviewed by the manufacturer. All risk mitigations, warnings and cautions are still correct, and in place. The device was not received for evaluation; therefore, a device analysis could not be completed. No further investigation required.
 
Manufacturer Narrative
(b)(4). A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made. The u. S importer is requesting manufacture of the device to further investigate this incident. The instruction manual for the home unit (model bp710n) has following warnings for the consumers: "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 instruction manual for the home unit (model bp710n) has following cautions for the consumers: "consult your physician before using the device for any of the following conditions: ·if you have had a mastectomy. ·do not take measurements more than necessary. It may cause bruising due to b blood flow interference. ·people with severe blood flow problems or blood disorders as cuff inflation can cause bruising. " a root cause has not been determined. It has not been confirmed that the blood pressure monitor provided if the device caused or contributed to the reported incident. However, due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.
 
Event Description
Consumer sent an email stating that he purchased the bp monitor less than a year ago. He has used it as needed and little over a week ago he used it and it really hurt him. Just as always on his left arm in the right position so he could get the most accurate reading and it quickly drove up way in the 200's and hurt him. The unit finally stopped inflating as he tried a rip the strap off his arm. He is now very bruised and over a week later his arm is very painful and sensitive to touch. He fears he might have damaged something inside his arm and has doctor's visit scheduled shortly. He is going to do some research to see if other's had this problem with your same device. There should be some kind of a safety switch on it to never go so high as to hurt someone and bruise them. During follow-up call, consumer stated he received a bruise from the unit and it is getting worse. He has had the unit for 5-6 months. He used the unit as he needed and he is the only user. The pain and bruising is going down his arm all the way to almost his wrist. This happened about a week ago. Consumer stated he is going to the doctor monday about the situation. He still has the pain and his arm is still very painful. He is not on any blood thinners or prone to bruising. He is upset there isn't an emergency button to hit in case the unit inflates too high. He may send the unit to an attorney before he sends it in for inspection. He is upset now he has to pay for doctor visit because of this. Qa stated will call him back after doctor's appointment. Consumer was sent a postage paid label to retrieve the unit for further investigation. Another follow-up call was made after consumer had the doctor visit. Consumer reported he went to the doctor on (b)(6) 2017. Consumer stated it turns out that he has now damaged arteries and blood flow is impeded in his left arm. His doctor recommended him to have ultrasound of his arm and it showed his has blood clot between elbow and wrist. He has been advised by his doctor to see a vascular specialist and they need to figure out how to dissolve the clot. Consumer stated his arm still swollen from upper arm to the wrist. He still has pain in his arm. He is (b)(6). Consumer is going to speak to his lawyer about this. Consumer stated he for sure does not own the cost of the visit to doctors and medication he needs to take now and treatment he is going to have for next 3 to 6 months. Consumer refused to provide details of medication he is taking and any preexisting medical conditions he has.
 
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Brand Name3 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 industrial p
hoa phu ward, 82000 0
VM 820000
Manufacturer (Section G)
OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
no. 28 vsip ii, st. 2
vietnam-singapore industrial p
hoa phu ward, 82000 0
VM 820000
Manufacturer Contact
renee thornborough
1925 w field court
suite 100
lake forest, IL 60045-4824
8472475626
MDR Report Key6946369
MDR Text Key247891818
Report Number3006852037-2017-00002
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBP710N
Device Catalogue NumberBP710N
Device Lot Number20160847489VG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/03/2017
Device Age13 MO
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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