MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 10 SERIES BLOOD PRESSURE MONITOR

Model Number BP786N

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The letter was received from the lawfirm and unable to reach consumer as directed by legal dept.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A root cause has not been determined.It has not been confirmed that the blood pressure monitor caused or contributed to the reported incident.No personal injury was reported.The preliminary investigation by insurance company identified that fire originated near an omron blood pressure monitor.The blood pressure monitor survived the fire.However, due to the report of the fire and in an abundance of caution, this medwatch is being filed.

Event Description

A letter was received on 5/10/2019 addressed to (b)(4).In the letter (potential subrogation claim) sent by (b)(6) the following information was provided related omron's blood pressure monitor.The loss was caused by a fire originating in the bathroom of consumer's house, where an omron blood pressure monitor was located.The fire and smoke caused substantial damage to the house and contents.The property loss is expected to amount to several hundred thousand dollars.No personal injuries were reported.The consumer's insurance company performed the preliminary investigation; findings were that the fire originated near an omron blood pressure monitor.A photo of the base of the blood pressure monitor, which survived the fire, was included with the letter.The insurance company placed the fire scene on hold, and invited omron to attend the joint scene inspection on may 22nd.After the inspection, the insurance company to hold a joint laboratory examination of the artifacts that to be harvested at the joint scene inspection.As of 05/24/2019, no further information has been received.

Manufacturer Narrative

Exemption number: e2013029.(b)(4).The manufacturer reviewed complaint history for the model number and similar models and complaint records for similar issues.No issue/problem was noted during data reviewed by the manufacturer.Unable to review manufacturing data, qa testing data or shipping information since no serial lot number provided.The device was not returned to manufacturer for investigation.However, the incident site and device was evaluated by the 3rd party (insurance company) and investigation summary was provided to the device manufacturer.Following information was provided by insurance company after preliminary evaluation.Our expert opined that it is unlikely that omron blood pressure monitor caused the bathroom fire.There were also a small radio and an amazon echo device near the fire origin.This loss involved mostly smoke damage and i would ballpark damages around (b)(6).There will be a subsequent lab artifact exam that is being set for (b)(6) on the three products.Then following supplementary information received.The artifact inspection has been moved to (b)(6).They'll x-ray the various products and may do destructive testing if necessary.This last exam should rule out our omron blood pressure monitor.The final investigation was completed on (b)(6) and additional details related to omron monitor was received on (b)(6) 2019.The experts disassembled omron unit and there were no visual electronic issues.They then tested the batteries and the circuitry and it was functioning normally.All experts on site agreed that omron product was not the fire cause.They then turned their attention to the radio and plan on a future ct scan.No further investigation required.

• Brand Name: OMRON 10 SERIES BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.; no. 28 vsip ii, st. 2,; vietnam-singapore indus. park; hoa phu thu dau mot city, 82000 0; VM 820000
• Manufacturer (Section G): OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.; no. 28 vsip ii, st. 2,; vietnam-singapore indus. park; hoa phu thu dau mot city, 82000 0; VM 820000
• Manufacturer Contact: renee thornborough ; 1925 w field court; suite 100; lake forest, IL 60045-4824 ; 8472475626
• MDR Report Key: 8642036
• MDR Text Key: 146116040
• Report Number: 3006852037-2019-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BP786N
• Device Catalogue Number: BP786N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/10/2019
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1