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

Model Number HEM-741CRELN4

Device Problem Low Readings (2460)

Patient Problem Cardiac Arrest (1762)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A postage paid label was sent to retrieve the unit for further investigation and verbal requests for unit return was made.Replacement unit was sent to customer to facilitate the retrieval of the unit for further investigation.The u.S importer is requesting the manufacturer of the device to further investigate this incident.The instruction manual for the home unit (model hem-741creln4) has following warnings for the consumers: "the monitor is not intended to be a diagnostic device." 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

The consumer reported that the unit gave him a low blood pressure (bp) reading (140/83 mmhg) on (b)(6) and one hour later, the emt got a reading of 175/115 mmhg.He was taken to the hospital and had a heart attack.He was in the hospital for 3 to 5 days and he had two stents implanted.The consumer stated he has no faith in the product.The consumer stated that he uses his left arm and that he is relaxed when taking his bp measurement.He takes his bp measurement at the kitchen table and applies the cuff to his left arm.His arm size is 12 inches.The consumer is using rayovac alkaline batteries.The consumer stated that he does not feel like answering any more questions.During following up call with quality analyst on (b)(6) 2018, consumer stated unit read low around 140/83 on (b)(6) and he went to the hospital because he was not feeling well.Consumer stated at the er his bp measurement was 175/115.Consumer stated he had a massive heart attack and was admitted for 5 days.He was not on blood pressure medication before the event, but now is.He now has stents.He had no previous history of heart issues.He had the unit for about 6 months and was using it every day.Consumer was sent postage paid label to retrieve the unit for further investigation and was provided with instructions for returning the unit to the inspection center.Consumer was also sent a replacement unit.Quality representative called the consumer again on (b)(6) 2018 and obtained the following information: the consumer stated that he had just received the replacement unit and requested the quality manager call him back to find out how replacement unit is working for him.Consumer confirmed he had a heart attack on (b)(6).Consumer stated he had a history of high blood pressure and was not on medication prior to his heart attack.They were trying to control his blood pressure without medication.He did not get any warning signs prior to having the heart attack.The quality manager requested that the consumer return the unit for further investigation.The consumer stated that he is planning to return the unit.

Manufacturer Narrative

Exemption number: e2013029.(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.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.

• Brand Name: RELION BP200 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
• MDR Report Key: 7825116
• MDR Text Key: 118525108
• Report Number: 3006852037-2018-00002
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00681131895408
• UDI-Public: (01)00681131895408
• Combination Product (y/n): N
• PMA/PMN Number: K133379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• 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: 20170303898VG
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/16/2018
• Device Age: 17 MO
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 109