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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOOD PRESSURE MONITOR UPPER ARM WITH LARGE BLOOD PRESSURE CUFF 8.7-16.5 INCHES SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NONINVASIVE

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BLOOD PRESSURE MONITOR UPPER ARM WITH LARGE BLOOD PRESSURE CUFF 8.7-16.5 INCHES SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NONINVASIVE Back to Search Results
Catalog Number B078ZD9Q8J
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Information (3190)
Event Date 12/05/2018
Event Type  Injury  
Event Description
Product i am reporting is the besuntek blood pressure monitor upper arm with large blood pressure cuff 8. 7-16. 5 inches and backlit lcd display fda approved. Device claims to be fda approved and it is not. Gives false results. Bought on (b)(6). Had test done at drs several times and brought in the device and the device was always wrong. Very dangerous product and should be taken off the market. Besuntek.
 
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Brand NameBLOOD PRESSURE MONITOR UPPER ARM WITH LARGE BLOOD PRESSURE CUFF 8.7-16.5 INCHES
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NONINVASIVE
MDR Report Key8214049
MDR Text Key132367892
Report NumberMW5082828
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2018
Device Catalogue NumberB078ZD9Q8J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/02/2019 Patient Sequence Number: 1
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