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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOMATIC B/P MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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AUTOMATIC B/P MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 01-539
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2020
Event Type  malfunction  
Event Description
I purchased a b/p monitor that is the only one offered using my (b)(6) healthcare over the counter dollars offered each month. The product smarttheart, model 01-539. This consistently gives 15-20 systolic and 10 point diastolic readings. This is verified by using another's product as well as having my son, who is a pt take the monitor to work and using this to take 8 other therapists b/p, and comparing them with department monitors. I have called my insurance who sent a replacement, the replacement has the same problem. This should be further explored and possibly taken off the market; smartheart. Fda safety report id # (b)(4).
 
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Brand NameAUTOMATIC B/P MONITOR
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
MDR Report Key10483572
MDR Text Key205520956
Report NumberMW5096394
Device Sequence Number2
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 08/31/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number01-539
Device Catalogue Number01-539
Was Device Available for Evaluation? No Answer Provided
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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