MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 1) 7 SERIES AUTOMATIC ARM BLUETOOTH; BLOOD PRESSURE MONITOR

Model Number BP761CAN

Device Problem Low Readings (2460)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Event occurred in (b)(6).Reporting in the u.S.Due to similar product sold in the u.S.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 customer reporting defibrillation and hospitalization was needed 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 sister called on his behalf.She stated that her brother's blood pressure was reading low on his omron device so she thought everything was okay.He stated that he was not feeling well so she took his pulse with a different device that was not omron.The reading was around 160 so she called 911 as soon as she could.She contacted the ambulance due to the reading and pain.On the way to the hospital, they had to use a defibrillator on him to revive him.At the hospital, they did an ekg and did other blood work for testing.He was diagnosed with an arrhythmia that he had no idea he had.He was released from the hospital later that day after hours of testing.When taking a reading, he used his left arm and sits at a table.He had only had the unit for about a year.It was verified that the consumer does follow all of the instructions in the manual.The sister was advised to stop using the unit and a replacement model would be sent.A paid postage label was sent to the consumer to retrieve the device for inspection.

Manufacturer Narrative

Event occurred in canada.Reporting in the u.S.Due to similar product sold in the u.S.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 customer reporting defibrillation and hospitalization was needed 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.Following sections were corrected: the consumer and contact person information was accidentally switched in the initial mdr.

Event Description

The consumer's sister called on his behalf.She stated that her brother's blood pressure was reading low on his omron device so she thought everything was okay.He stated that he was not feeling well so she took his pulse with a different device that was not omron.The reading was around 160 so she called 911 as soon as she could.She contacted the ambulance due to the reading and pain.On the way to the hospital, they had to use a defibrillator on him to revive him.At the hospital, they did an ekg and did other blood work for testing.He was diagnosed with an arrhythmia that he had no idea he had.He was released from the hospital later that day after hours of testing.When taking a reading, he used his left arm and sits at a table.He had only had the unit for about a year.It was verified that the consumer does follow all of the instructions in the manual.The sister was advised to stop using the unit and a replacement model would be sent.A paid postage label was sent to the consumer to retrieve the device for inspection.

Manufacturer Narrative

Event occurred in canada.Reporting in the u.S.Due to similar product sold in the u.S.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 customer reporting defibrillation and hospitalization was needed 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.Additional information added to section h10.A postage paid label was sent to retrieve the unit for further investigation from importer.The manufacturer reviewed the qa test data/shipping inspection data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.The risk analysis document was reviewed and similar risk has been analyzed.As of mar 15, 2022, unit was not returned by consumer to the distributor/manufacturer.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

Event Description

The consumer's sister called on his behalf.She stated that her brother's blood pressure was reading low on his omron device so she thought everything was okay.He stated that he was not feeling well so she took his pulse with a different device that was not omron.The reading was around 160 so she called 911 as soon as she could.She contacted the ambulance due to the reading and pain.On the way to the hospital, they had to use a defibrillator on him to revive him.At the hospital, they did an ekg and did other blood work for testing.He was diagnosed with an arrhythmia that he had no idea he had.He was released from the hospital later that day after hours of testing.When taking a reading, he used his left arm and sits at a table.He had only had the unit for about a year.It was verified that the consumer does follow all of the instructions in the manual.The sister was advised to stop using the unit and a replacement model would be sent.A paid postage label was sent to the consumer to retrieve the device for inspection.

• Brand Name: 7 SERIES AUTOMATIC ARM BLUETOOTH
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 1); no. 3 songjiang rd., economic; technical development zone; dalian, 11660 0; CH 116600
• MDR Report Key: 13102221
• MDR Text Key: 285188390
• Report Number: 1450057-2021-00008
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BP761CAN
• Device Catalogue Number: BP761CAN
• Device Lot Number: 201602LG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2021
• Distributor Facility Aware Date: 12/21/2021
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 12/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Male