• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 10 SERIES UPPER ARM BLOOD PRESSURE MONITOR Back to Search Results
Model Number BP7450
Device Problems Fire (1245); 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. The u. S importer is requesting the manufacturer of the device to further investigate this incident.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMRON 10 SERIES UPPER ARM BLOOD PRESSURE MONITOR
Type of DeviceBLOOD 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 Key11592673
MDR Text Key243059266
Report Number1450057-2021-00003
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBP7450
Device Catalogue NumberBP7450
Device Lot Number201909V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2021
Distributor Facility Aware Date03/24/2021
Device Age18 MO
Event Location Home
Date Report to Manufacturer03/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-