MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. RELION BP200 BLOOD PRESSURE MONITOR; AUTOMATIC BLOOD PRESSURE MONITOR

Model Number HEM-741CRELN4

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

Patient Problem Hematoma (1884)

Event Date 03/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A postage paid label has been sent to retrieve the unit for further investigation.The u.S importer is requesting manufacturer of the device to further investigate this incident.The instruction manual for the home unit (model hem-741creln4) 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.People with severe blood flow problems or blood disorders as cuff inflation can cause bruising".Device not returned.

Event Description

Consumer had initially reported on (b)(6) 2016 to the retailer indicating his bp monitor kept inflating until 300 and it left bruises on the arm.He had to go to the hospital because he was on blood thinners and something happened to his veins.He went back to retailer to get his money back and retailer would not accept it.The retailer contacted the importer/distributor and requested to contact consumer.Consumer was contacted (on (b)(4) 2016) by the importer/distributor to obtain additional information.Consumer reported he has a bruise on the upper arm.The unit was in inflation mode and it had pumped up all the way and it would not stop pumping and they finally had to unplug the cuff for the unit to make it stop putting up.He tried to return the bp monitor to retailer.He is on blood thinners and it has created a bruise and he did go to the er to have the bruise checked out but he was not admitted and they did not change his meds and they did not give him anything for it.The cuff was snugged.He is only user and is supposed to use it three times a day.He uses his left arm.The cuff was on his bare arm not over a shirt.He was sitting on a hard chair with feet on floor.The cuff inflated up to 300.His average reading is 185/123.He has never had this issue before.The left arm and the bruise were dark and it covered the whole upper arm.Consumer indicated once again he is on blood thinner.It has been three days for the bruise.Consumer was advised to stop using the unit and was asked to return the unit further investigation via postage paid label that was sent to him.During follow-up call with quality analyst (qa) on (b)(6) 2016, consumer stated he purchased the unit last friday and on saturday he noticed his bruise.Consumer stated he is on blood thinners.The bruise was dark and he went to the er to have it checked out.The er took him off of his blood thinners and gave him medication to prevent clotting and for the pain.Consumer stated he was not admitted.He still has the bruise but it is small.He uses the unit 3 times a day.Consumer has not replaced the cuff.Consumer reported he is not sure if he will return the unit as he is speaking to his lawyer regarding next steps.Qa informed consumer a postage paid label has been sent and requested to return the unit for further investigation and replacement unit will be sent to him.Consumer sent an email on (b)(6) 2016 indicating he was called yesterday about this defective product.He was told he was going to receive a shipping label via email, to return the unit.After further discussion with family, he is going to contact an attorney about injuries he received while using this item.He is still out the cost of purchasing the bp200, plus the cost of an er room visit, and the cost of replacing the blood pressure monitor.Not to mention his time lost, and pain suffered.Consumer called back again on (b)(6) 2016 and indicated the he was using left arm, unit caused the bruise which turned into a blood clot and was admitted over the weekend.He stopped using product before he called omron to report problem.He is taking product to his lawyers.Consumer was advised a postage paid label has been sent for retrieval of the unit.Quality analyst called again consumer on (b)(4) 2016 to obtain additional information.Consumer stated he purchased the unit on (b)(6) 2016 per his doctor's recommendation.Consumer reported that saturday, (b)(6) 2016 he went to the hospital and was admitted for a blood clot.Consumer stated they ran too many tests for him to remember specifically which tests were executed.He saw his doctor yesterday, (b)(6) 2016 where the doctor evaluated him, put him on new medication and adjusted the dosage of his current medication.Consumer stated all of the medication he is taking is a result of the blood clot and his high blood pressure/hypertension.Consumer stated he is on about 4-5 different medications but would not provide their names.Consumer stated he has been on blood thinners since (b)(6) 2015.

Manufacturer Narrative

(b)(4).Verbal requests were made to retrieve the unit.In addition, postage paid labels were sent to retrieve the unit back for inspection.However, the end-user consumer did not return the home blood pressure monitor for inspection.The device was not received for evaluation; therefore, a device analysis could not be completed.The manufacturer reviewed the device history record, qa test data, and risk analysis, complaint history for the model number and similar models and complaint records for similar issues.No issue/problem was noted during data reviewed by the manufacturer.All risk mitigations, warnings and cautions are still correct, and in place.No further investigation required.

• Brand Name: RELION BP200 BLOOD PRESSURE MONITOR
• Type of Device: AUTOMATIC BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.; no. 28 vsip ii, st. 2; vietnam-singapore industrial p; hoa phu ward, thu dau mot city 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, thu dau mot city 82000 0; VM 820000
• Manufacturer Contact: renee thornborough ; omron healthcare, inc.; 1925 w field court, suite' 100; lake forest, IL 60045-4824 ; 8472475626
• MDR Report Key: 5529758
• MDR Text Key: 41312488
• Report Number: 3006852037-2016-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HEM-741CRELN4
• Device Catalogue Number: HEM-741CRELN4
• Device Lot Number: 20151018199VG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/19/2016
• Device Age: 4 MO
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 03/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 113