MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 10 SERIES BLOOD PRESSURE MONITOR

Model Number BP786N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 05/28/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Verbal requests were made to advise consumer to return the unit.Consumer was offered both a replacement unit and a refund to facilitate the retrieval of the unit for investigation.Consumer refused to send the unit back since it is working.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A root cause has not been determined.It has not been confirmed that the blood pressure monitor 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 reported that unit was not providing a reading.Consumer stated the unit is inflating and deflating but not providing a reading.The unit would not provide a reading for her husband and had she known his blood pressure was as high as it was her husband may not have died from a leaking aneurysm.Consumer stated that the unit still would not work on herself.Caller states she would really like a refund.Customer service representative advised consumer that the truread mode is on and assisted turning the feature off.Consumer was advised caller to take a bp reading and caller received a reading.Quality manager (qm) called consumer and apologized for consumer's loss of her husband and offered a refund and replacement unit.Consumer stated since the unit is working, let's just forget about it.Consumer stated the customer service agent helped her this morning and she was able to get her blood pressure (bp) measurement.She had small procedure done couple of days ago and was trying to take her bp measurement recently and was not able.But now the unit is working.Consumer confirmed her husband passed away about 3 months ago.Consumer stated her husband had tons of problems prior to him passing away.He had skin cancer that was not treatable and had lots of other issues.She was trying to take his bp measurement two days prior to him passing away and she was not able to get readings.Consumer stated she had called home health nurse on friday but the nurse does not come over the weekend.He passed away on monday (memorial day) prior to the nurse visiting him.She may have been very upset about it to deal with.Consumer stated to quality manager (qm) to remember it is very difficult to deal with loss of husband when you are not young anymore.Qm explained that the truread feature was on.Qm again apologized for her loss and offered to refund and a replacement and requested to return the unit.Consumer again politely declined the offer and stated not worry about it.Qm provided phone number in case consumer decides to get refund and/or replacement at later time.Consumer did not want to provide additional information.

Manufacturer Narrative

(b)(4).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.The instructions manual has the instructions for setting tru read mode.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: OMRON 10 SERIES 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, binh duong 82000 0; VM 820000
• Manufacturer (Section G): OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.; no. 28 vsip ii, st. 2,; vietnam-singapore indus. park; hoa phu thu dau mot city, binh duong 82000 0; VM 820000
• Manufacturer Contact: renee thornborough ; 1925 w field court; suite 100; lake forest, IL 60045-4824 ; 8472475626
• MDR Report Key: 7838779
• MDR Text Key: 118949950
• Report Number: 3006852037-2018-00003
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00073796267865
• UDI-Public: (01)00073796267865
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BP786N
• Device Catalogue Number: BP786N
• Device Lot Number: 20160602280VG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/27/2018
• Device Age: 26 MO
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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): Death