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

Model Number	BP7250
Medical Device Problem Codes	Fire (1245); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer was inquiring on purchasing a new ac adapter for her bp7250 unit.She stated the ac adapter caught fire but no one was hurt.She was advised to make sure to properly dispose of the adapter.She stated she will not accept calls so the supervisor will need to email her to follow-up.Omron customer service representative sent multiple emails requesting additional details.The consumer has not answered any emails to follow-up.
Additional Manufacturer Narrative
A postage label has been sent for retrieval of the home unit for inspection.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 the adapter caught fire this medwatch is being filed.
Additional Manufacturer Narrative
The device was not returned to the distributor/manufacturer for investigation.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.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: 14506023
• Report Number: 8030245-2022-00004
• Device Sequence Number: 14926988
• Product Code: DXN
• UDI-Device Identifier: 00073796267254
• UDI-Public: (01)00073796267254
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BP7250
• Device Catalogue Number: BP7250
• Device Lot Number: 202008V
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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
• Patient Sex: Female