MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD 5 SERIES CONNECTED UPPER ARM BLOOD PRESSURE MONITOR

Model Number	BP7250
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer stated her unit had been reading high at the doctor's office.Her unit read 168/92-96 and her doctor's unit read 130/60.She has bought several omron units and keeps buying them.She went to the omron website to see if she could calibrate the unit.She was the only user.She used the unit three times a day.She used her left arm with the cuff right above her elbow bend and the air hose went to the side of her arm.She would take a reading on her bed with her legs straight out or on her living room chair with her feet flat on the floor.She would not talk or move during the reading.She stated that her cuff was the correct size for her arm.She stated she had a stroke the week of (b)(6) 2023.During a follow-up, she stated she does not have any family.She stated her omron units keep breaking down so she buys another one.She stated she bought this unit in 2022.When her doctor did a machine comparison, he would take the readings simultaneously on each arm with his unit on her right arm and the omron unit on her left arm.They had also done comparison readings on the same arm, waiting 2-4 minutes in between.She took her readings 3 times a day and used the original cuff that came with the unit.She would take her medication when her readings are over 120.She called 911 everytime her blood pressure got too high.She stated she had a stroke during the week of 3/13/2023 and ended up in the hospital.She stated she had a couple of strokes over the last 2 years, and she suffers from high blood pressure that she managed through medication.She stated her doctor was a cardiologist.She also stated she was seeing a physical therapist for her balance, but it was unrelated to the event.
Additional Manufacturer Narrative
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 being hospitalized as a result of a stroke this medwatch is being filed.The product instruction manual includes following warnings: - do not adjust medication based on readings from this blood pressure monitor.Take medication as prescribed by your physician.Only a physician is qualified to diagnose and treat high blood pressure.- never diagnose or treat yourself based on your readings.Always consult with your physician.A postage label has been sent for retrieval of the home unit for inspection.A replacement unit was sent to the consumer.
Additional Manufacturer Narrative
The device was not returned to the distributor/manufacturer for investigation and the investigation was closed on 6/30/2023.Here is the summary of the manufacturer device investigation: 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.There was one similar event reported for the same model in the past.However, no abnormal trend was identified.Unit was not returned by consumer.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: 5 SERIES CONNECTED UPPER ARM BLOOD PRESSURE MONITOR
• Common Device Name: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer (Section G): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer Contact: tomoji zukawa ; 53 kunotsubo; terado-cho; muko-city, kyoto 61700-02 ; JA 6170002
• MDR Report Key: 16697305
• Report Number: 8030245-2023-00004
• Device Sequence Number: 5670410
• Product Code: DXN
• UDI-Device Identifier: 00073796267254
• UDI-Public: (01)00073796267254
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: BP7250
• Device Catalogue Number: BP7250
• Device Lot Number: 202107V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female