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	Syncope/Fainting (4411)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Postage paid label was sent to retrieve the unit for further investigation and the request for unit return was made.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 hospitalization and receiving medical treatment, this medwatch is being filed.
Event or Problem Description
The consumer reported she received an omron upper arm blood pressure monitor, bp7250, as a gift.The unit was recommended by her doctor.After monitoring her blood pressure for awhile, she sent the results to her doctor.Since they were extremely high readings, her doctor decided to change and adjust her blood pressure medications.The consumer stated that this change in medication resulted in her collapsing and spending 4 days in the hospital to control her blood pressure.She met with her doctor on 2 different occasions after this.She brought in her omron monitor and compared the readings with her doctor's monitor.Her doctor took a reading twice with his unit results averaging 130/70 and the omron device averaging 180/93.Multiple attempts were made by omron to contact the consumer for additional information, but the consumer did not answer.Follow-up calls were made on 1/17/22, 1/18/22, 1/19/22, 1/21/22, 1/24/22, and 1/27/22.
Additional Manufacturer Narrative
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.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: 13408755
• Report Number: 8030245-2022-00001
• Device Sequence Number: 17367847
• Product Code: DXN
• UDI-Device Identifier: 00073796267254
• UDI-Public: (01)00073796267254
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 02/01/2022

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: 202106V
• 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: 01/29/2022
• Supplement Date Received by Manufacturer: 01/29/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Female