• 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 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR 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 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR, Back to Search Results
Model Number BP7100
Device Problem High Readings (2459)
Patient Problems Fainting (1847); Bone Fracture(s) (1870); Laceration(s) (1946); Electrolyte Imbalance (2196)
Event Date 03/03/2020
Event Type  Injury  
Manufacturer Narrative
The instruction manual for the home unit (model bp7100) has following warning listed. "do not adjust medication based on readings from this blood pressure monitor. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure. " "never diagnose or treat yourself based on your readings. Always consult with your physician. " 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 hospitalization and receiving medical treatment, 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 unit was reading high and was given a medication based on those readings. After the medication change, she fainted twice, was injured, and was in the hospital for 36 hours. She is the only user, using it three times a day and has had unit since (b)(6) 2020. Per consumer, the unit has been reading high from the first use. The cuff size is correct and the cuff was secured. The average blood pressure when using this machine was in the ~ high range of 130's over high 80's. At the doctor's office, her reading was 114/76. Consumer stated at the doctor's office, omron unit inflated to 150 to 170 and gave reading of 140/90. At the hospital, her reading was very low. After a sodium drip, it came up to more normal reading. Consume stated her home unit read high so she called doctor and doctor changed her medication to diuretic. The customer fainted twice and her pressure at that time was 72/56. At the hospital, her medication was changed at the hospital. The customer was in the hospital for 36 hours. She had a broken thumb and facial lacerations. Blood work and echocardiogram. X-rays of hand and chest. Cat scan for brain bleed. During follow-up call on (b)(6), consumer stated the omron unit was reading high so she called her doctor and her doctor prescribed diuretic to add along with her current medication. The diuretic depleted the sodium in her system causing her to faint. Consumer stated she has a broken thumb and a laceration over the left eyebrow. Consumer was told that the laceration was deep but it was a clean cut so they were able to glue it shut. Consumer reported it did bleed a lot but that is common for head injuries. They gave her a sodium drip to get her levels back up. The thumb has a fracture through it and is in a splint. They did blood work, echocardiogram. X-rays of hand and chest, and cat scan for brain bleed. Consumer indicated a side from x-ray showing the fracture and the blood work showing the low sodium, all of the other testing came back okay and once her sodium came back up they were able to discharge her. Consumer would like get the refund for the unit. Consumer was advised not to adjust medication based on the measurement results from the blood pressure monitor and only physician is qualified to diagnose and treat high blood pressure. A refund request was submitted and a postage paid label was sent for retrieval of the home unit for further investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMRON 3 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 Key9819547
MDR Text Key190511865
Report Number1450057-2020-00001
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 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBP7100
Device Catalogue NumberBP7100
Device Lot Number201905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2020
Distributor Facility Aware Date03/09/2020
Device Age10 MO
Event Location Home
Date Report to Manufacturer03/11/2020
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

Patient Treatment Data
Date Received: 03/11/2020 Patient Sequence Number: 1
-
-