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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,

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OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR, Back to Search Results
Model Number BP710N
Device Problem Low Readings (2460)
Patient Problems Cardiac Arrest (1762); Pneumothorax (2012); Dizziness (2194)
Event Date 06/25/2019
Event Type  Injury  
Event Description
Consumer reported the unit is reading low on his mother. On (b)(6) 2019 he called 911 for his mother because of her blood pressure (bp). His mother was laying on the bed. Consumer stated unit is used by two users and using sunbeam batteries. His mother was laying on the bed when they took the bp reading. Consumer was advised to sit in the chair while taking bp measurements by customer service representative. The cuff was applied on his mother's left arm on bare skin snug where they cannot fit anything under it. Consumer did not remember how high the cuff inflated nor the reading at the doctor's office. His mother takes readings three times a day with unit. His mother's arm circumference is 9 1/2 inches. Her medication was changed by the doctor and then she was released within an hour. There was no test done on his mother. Consumer was advised to not to use the unit and sent a postage paid label to retrieve the unit for further testing. On july 16, 2019, quality analyst called consumer to obtain additional information. There was no answer. Quality analyst left a voice mail requesting a call. During a follow-up call with the quality department on 7/17/2019, consumer stated this incident occurred when he and his mom went to a wedding. She was having dizziness so she took her bp, 138/65, and sat down for a while. She felt better but was still lightheaded so she took a nitroglycerin. Her bp went down to 45/38. She collapsed and her heart stopped. Three ribs were broken and her lung collapsed from the cpr. It took 10 minutes to get her back. One doctor told her it was a heart attack and another told her it wasn't a heart attack. When she got home her bp was low on her home bp monitor even though she felt fine so her son took her to the er. Her bp there was normal. When comparing the home bp monitor to the doctor's, the hbp was reading low. Son bought a new series 7 monitor that he checked against manual stethoscope. She has testing in the future to try to determine the cause of the incident. Consumer stated his mom is (b)(6) years old and lives alone, exercises at least twice a week and walks a 3/4 mile everyday - 1 mile before the incident. She takes aspirin in the morning, simvastatin, metoprolol, levothyroxine, nitroglycerin as needed, and has a lidocaine patch. Consumer confirmed they will return the unit for testing. Quality representative called consumer again on 7/25/2019 to obtain additional clarification related to the incident. Unable to leave a voicemail since the consumer's voicemail box was full. Quality representative called consumer again on 7/26/2019. Consumer provided same information again which was already documented in the case and then stated her cardiologist believes she still has heart issue.
 
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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 Key8833250
MDR Text Key152477069
Report Number1450057-2019-00002
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 07/26/2019,07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBP710N
Device Catalogue NumberBP710N
Device Lot Number20161014485VG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2019
Distributor Facility Aware Date07/15/2019
Device Age33 MO
Event Location Other
Date Report to Manufacturer07/26/2019
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: 07/26/2019 Patient Sequence Number: 1
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