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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUR PRESSURE SMART BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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PUR PRESSURE SMART BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number U80EH
Device Problem Failure to Shut Off (2939)
Patient Problems Stroke/CVA (1770); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)
Event Date 06/29/2019
Event Type  Injury  
Event Description
After suffering what was most likely a tia stroke, the drs told me to buy a quality blood monitoring device. The pur pressure smart blood pressure monitor was recommended on our (b)(6). Here is his website with the pur pressure smart blood pressure monitor. (b)(4)/ the monitor worked for less than 24 hours and the final time i used, it would not turn off. The cuff was expanding around my arm and got so tight, my arm turned purple and i could not get the cuff off. It would not turn off regardless of what button i pushed. Finally in a panic, i ripped the cord connecting the cuff to the machine out of the machine. Air came out, so my arm was no longer in danger, but the machine kept running. The only way to turn off the machine is to take out the batteries, not an easy thing to do especially when the cuff is expanding. A day later the machine will still run when the batteries are put in. This is a very dangerous product, in my opinion. I was not permanently injured although stress following a tia stroke is not a good thing. I reread the safety instructions and there is nothing even remotely mentioned related what to do in this circumstance. I have kept the machine, the packaging, the instructions and the new batteries (exp 2/2028). (b)(4); purchase date: (b)(6) 2019. (b)(4).
 
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Brand NamePUR PRESSURE SMART BLOOD PRESSURE MONITOR
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
MDR Report Key8795229
MDR Text Key151561710
Report NumberMW5088186
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 Patient
Type of Report Initial
Report Date 07/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberU80EH
Was Device Available for Evaluation? Yes
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

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