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

Model Number BP7450

Device Problems Smoking (1585); Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

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 device caused or contributed to the reported incident.However, due to the customer reporting ac adapter sparking and flames coming from the side of the unit with a burning smell this medwatch is being filed.

Event Description

Consumer reported that the ac adapter is on fire.The ac adapter sparking and flames coming from the side of the unit with a burning smell.It was not sparking or fire from the wall socket; just the unit.The unit does not turn on now with just batteries.Consumer changed the batteries and no power with new batteries.Consumer stated there was no property damage.He pulled the plug out of the wall and then out of the unit.He is using the original ac adapter with the unit and verified that ac adapter part number was hem-adptw5.Per consumer, the unit the unit was plugged into the out let on march 17th and this issue happened on march 22nd.The unit was on kitchen counter.Consumer stated fire depart was not called.Omron customer service representative sent postage paid label and advised consumer to return the unit the unit using postage paid label for further investigation.During follow-up call, consumer stated the unit caught on fire and this happened on march 22nd.They smelt something burning and stated searching in the kitchen to find where the smell was coming from.It smelt like burnt plastic.The unit was actually on fire.He used the towels to put the fire out.The fire was coming from the back of the unit where the ac adapter was plugged in.The cord was on fire and the back of the unit was melted.The unit was sitting on the counter and they kept it plugged in the wall outlet.There was no any damage to his personal property just the machine was melted.He was not harmed in anyway.He just used some towels to put the small flame out.Consumer as using omron adapter hem-adptw5.A new unit was send to consumer and request to return his back was made.Consumer stated as soon as he receives the shipping label in his email he would send the unit back to for testing.

Manufacturer Narrative

Updated information in section h10 after investigation by manufacturer: after initial report was submitted, consumer returned the unit back to importer.The importer evaluated the returned unit and then sent the device to manufacturer for further investigation.Here is the summary of the manufacturer device investigation: the manufacturer performed visual inspection of the returned product and found that casing was melted and burnt around the ac adapter hole.The unit powered on with batteries.A large burn mark was found around the dc plug insertion port on the side of the main unit.After applying 6v from a regulated power supply and starting the main unit, the current consumption inspection was carried out according to the shipping inspection standard.After confirming the conformity of the current consumption test results, the blood pressure was measured by connecting the cuff possessed by qa-g.It was confirmed that the blood pressure of the human body could be measured normally.The unit was opened to investigate inside and it was confirmed that there was no burning mark due to the flame inside the dc jack and the housing, and that the ignition was not from inside the main body.Melting of the dc plug, disconnection of the cord, and melting of the cord coating were found.The test confirmed that the coating was torn at the location where the cord was broken.The test measured electrical characteristics of the returned ac adapter (hhp-am01 / hem-adptw5) and confirmed it was within specification limit.It was concluded that there was no electrical abnormality in the main body of the blood pressure monitor or the ac adapter, it was operating normally, and no burn marks were found inside the unit.Therefore, the investigation determined that the burn marks on the side of the main unit and the dc plug of the ac adapter are potentially caused by external ignition.It is presumed that the melting of the coating around the disconnection of the adapter cord was caused by external ignition, but the cause of the disconnection could not be identified.The manufacturer reviewed the qa test data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.No issue or increasing trend was noted.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.Since the product is operating normally with batteries and external power supply; it cannot be confirmed that product failure caused the ignition phenomenon reported by user; further action is not required.

• Brand Name: OMRON 10 SERIES UPPER ARM BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD.; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• MDR Report Key: 11600998
• MDR Text Key: 243311351
• Report Number: 8030245-2021-00003
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00073796267452
• UDI-Public: (01)00073796267452
• Combination Product (y/n): Y
• PMA/PMN Number: K133383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BP7450
• Device Catalogue Number: BP7450
• Device Lot Number: 201909V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 79