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

Catalog Number B078ZD9Q8J

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

• Brand Name: BLOOD PRESSURE MONITOR UPPER ARM WITH LARGE BLOOD PRESSURE CUFF 8.7-16.5 INCHES
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NONINVASIVE
• MDR Report Key: 8214049
• MDR Text Key: 132367892
• Report Number: MW5082828
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• 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 Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Catalogue Number: B078ZD9Q8J
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR