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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIATEK INC. SN60 PLUS SMARTWATCH SYSTEM, MEASUREMENT, BLOOD PRESSURE NON-INVASIVE

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MEDIATEK INC. SN60 PLUS SMARTWATCH SYSTEM, MEASUREMENT, BLOOD PRESSURE NON-INVASIVE Back to Search Results
Model Number SN 60 PLUS
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  malfunction  
Event Description
I purchased a sn60 plus smartwatch that purports to measure arterial blood pressure. I have long standing hypertension and use an omron home pressure system. I compared the watch bp with the cuff traditional bp and there was no correlation. Never less than 20 mmhg error on systolic and as much as 49 mmhg. Diastolic bp was never less than 25 mmhg off. I purchased the watch from spade and company. The mfr is (b)(4). The watch uses blinking green lights to "measure" bp. There is no arterial compression. Most of the watch bp's were within 1-2 mm of the last regardless of my cuff pressure. (b)(4).
 
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Brand NameSN60 PLUS SMARTWATCH
Type of DeviceSYSTEM, MEASUREMENT, BLOOD PRESSURE NON-INVASIVE
Manufacturer (Section D)
MEDIATEK INC.
MDR Report Key8527790
MDR Text Key142544375
Report NumberMW5085971
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 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN 60 PLUS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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: 04/17/2019 Patient Sequence Number: 1
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