MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 7 SERIES BLOOD PRESSURE MONITOR

Model Number BP760N

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 03/25/2021

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 overheated, sparked and black smoke came out of wall outlet, this medwatch is being filed.The ac adapter is not manufactured by omron.The u.S importer is requesting the manufacturer of the device to further investigate this incident.

Event Description

Consumer reported ac adapter overheated and blew up while unplugging from the wall.Consumer is using adapter hqrp wcz 100--240vac 50/60hz.Omron customer service representative informed consumer that this adapter is not manufactured by omron and advised to use omron manufactured parts with omron blood pressure monitor.Consumer stated that the adapter was plugged in to the wall outlet with nothing else plugged in.There was a spark and cloud of smoke and it left a scorch mark on the outlet cover.Consumer stated there were no other damage or injuries.The unit was on counter and left plugged in for about a week before incident.The unit still working normally with batteries.She is the only user and uses it once a day.Omron customer service representative sent postage paid label to retrieve the unit for further investigation.During follow-up call, consumer stated the unit works fine but the adapter went "crazy".Consumer stated she smelled a burning smell and so she unplugged the blood pressure monitor.When she unplugged the adapter, it sparked and black smoke came out of the wall outlet.The unit was plugged directly into wall with nothing else.Consumer stated nothing felt hot to her and the unit is working just fine with batteries.Consumer confirmed she is using non-omron adapter hqrp wcz 100--240vac 50/60hz.Consumer was advised omron units are part specific.She did not know that and amazon had this adapter advertised as compatible with omron units.Consumer was given an option to get refund or replacement for the unit.Consumer was sent a new unit with ac adapter.

Event Description

Consumer reported ac adapter overheated and blew up while unplugging from the wall.Consumer is using adapter hqrp wcz 100--240vac 50/60hz.Omron customer service representative informed consumer that this adapter is not manufactured by omron and advised to use omron manufactured parts with omron blood pressure monitor.Consumer stated that the adapter was plugged in to the wall outlet with nothing else plugged in.There was a spark and cloud of smoke and it left a scorch mark on the outlet cover.Consumer stated there were no other damage or injuries.The unit was on counter and left plugged in for about a week before incident.The unit still working normally with batteries.She is the only user and uses it once a day.Omron customer service representative sent postage paid label to retrieve the unit for further investigation.During follow-up call, consumer stated the unit works fine but the adapter went "crazy".Consumer stated she smelled a burning smell and so she unplugged the blood pressure monitor.When she unplugged the adapter, it sparked and black smoke came out of the wall outlet.The unit was plugged directly into wall with nothing else.Consumer stated nothing felt hot to her and the unit is working just fine with batteries.Consumer confirmed she is using non-omron adapter hqrp wcz 100--240vac 50/60hz.Consumer was advised omron units are part specific.She did not know that and amazon had this adapter advertised as compatible with omron units.Consumer was given an option to get refund or replacement for the unit.Consumer was sent a new unit with ac adapter.

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 overheated, sparked and black smoke came out of wall outlet, this medwatch is being filed.The ac adapter is not manufactured by omron.The u.S importer is requesting the manufacturer of the device to further investigate this incident.Updated data: section d9- unit returned by consumer after initial mdr was submitted so section d9 updated accordingly.Updated information in section h10 after investigation performed by manufacturer: after initial report was submitted, consumer returned the unit back to the 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 ac adapter was broken and was burned.The returned product passed compliance check using sample ac adapter.[current consumption] at pump on: 314ma (standard: 520ma or less).Stand-by: 5.4ma (standard: 50ma or less).Dark current: 38 microampere (standard: 80 microampere or less).[maximum current waveform].Maximum current value: about 360ma (at the start of pump drive).[non-omron ac adapter (hqrp wcz)] there was a burnt mark on the board pattern on the primary side (ac side) of the ac adapter, and the resistor and ic on the primary side (ac side) were damaged.From the following two points, it is determined that omron blood pressure monitor is not the cause of the failed non-omron adapter (hqrp ac adapter).1.Since the consumption current was normal and the basic characteristics measured by the manufacturer were conforming, blood pressure monitor did not malfunction.2.The output rating of the non-omron ac adapter is dc6v 1a.The current consumption of the bpm was 400ma or less, and it did not exceed 1a.The investigation conclusion was that non-omron had some issue; which caused the customer reported incident.As reported by consumer, the consumer was using non-omron ac adapter (hqrp ac adapter).Consumer stated that amazon has this adapter advertised as compatible with omron bpm.The importer contacted amazon account manager and notified of this incident and pointed out advertisement of non-omron ac adapter on their site.Following caution statement is provided in the instruction manual: use only an omron ac adapter designed for this device.Use of unsupported adapters may damage and/or may be hazardous to the device.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 omron blood pressure monitor was operating as expected, further action is not required.

• Brand Name: OMRON 7 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
• MDR Report Key: 11602757
• MDR Text Key: 243366033
• Report Number: 1450057-2021-00004
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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: Lay User/Patient
• Device Model Number: BP760N
• Device Catalogue Number: BP760N
• Device Lot Number: 201611VG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2021
• Distributor Facility Aware Date: 03/25/2021
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1