MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD. 10 SERIES WIRELESS UPPER ARM BLOOD PRESSURE MONITOR

Model Number	BP786N
Medical Device Problem Codes	Fire (1245); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported that his ac adapter caught fire while it was plugged into the wall.He pulled the plug and doused the fire out then threw away the adapter.He had the part number for the adapter.It was requested that he send any photos or screenshots of the damage.No photos have been sent.He repaired the outlet at minimal cost.During a follow-up call, the consumer stated the ac adapter melted the outlet due to overheating.There was not a fire in the outlet or radiating up the wall.The issue occurred about 3 weeks ago.The unit would work properly while operating with batteries.He was using the ac adapter that came with the unit, hem-adptw5.He no longer had the adapter to verify the model number.He assessed the outlet by taking it apart and verifying that the ac adapter caused the damage.He had been using the unit for 2 years but not consistently.He did not leave the adapter plugged into the outlet and only used the unit every once in a while.Only the unit was plugged into the outlet.The outlet was inside with no moisture.The unit was plugged directly into the outlet.It was requested that the consumer send in the unit and a replacement bp7450 would be sent.
Additional Manufacturer Narrative
A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.A root cause has not been determined.It has not been confirmed if the adapter caused or contributed to the reported incident.However, due to the customer reporting the ac adapter caused a fire, this medwatch is being filed.
Additional Manufacturer Narrative
Additional information : after initial report was submitted, consumer returned the unit back to importer for evaluation.The importer evaluated the returned unit and it passed evaluation.Then, the returned unit was sent to device manufacturer for further testing.Here is the summary of the manufacturer device investigation: since the actual ac adapter was not returned, it is not possible to investigate and/or risk analyze this event.The main unit was returned and it was determined the returned blood pressure monitor was is normal working condition.There are three probable causes of fire from the ac adapter.They are as follows: overload, destruction of internal parts due to lightning surges, and tracking phenomenon.During a previous investigation, the relationship between the factors and this model of ac adapter was verified, and it was confirmed that the possibility of fire is low for each cause.Also, since the main unit's results were within specifications, it was determined the main unit did not overload the ac adapter.The manufacturer reviewed the qa test data/inspection data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.The manufacturer reviewed/conducted risk analysis and noted that the severity of the nonconformity was similar to "fire from product", and there was one other previous case with a similar complaint.The manufacturer determined no further investigation is required due to: investigation of nonconforming product and identification of the cause is not possible due to ac adapter not returned, and it was confirmed that there is a low possibility of ignition from the ac adapter.

• Brand Name: 10 SERIES WIRELESS 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: 13717833
• Report Number: 8030245-2022-00002
• Device Sequence Number: 11885792
• Product Code: DXN
• UDI-Device Identifier: 00073796267865
• UDI-Public: (01)00073796267865
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133383
• 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): 03/10/2022

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: BP786N
• Device Catalogue Number: BP786N
• Device Lot Number: 201808VG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2018
• 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: Male