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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALGREENS WALGREENS 960BT SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE

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WALGREENS WALGREENS 960BT SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE Back to Search Results
Model Number WGNSPS-960BT
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2019
Event Type  malfunction  
Event Description
I purchased the walgreens blood pressure monitor 960bt. This is a bluetooth device that is supposed to connect to an ios device, using (b)(6) connect app. Trying to connect this to my phone or ipad the app says device not supported even though the app has this as a product that it supports. I checked online and this has been going on since (b)(6) of 2018.
 
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Brand NameWALGREENS 960BT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
Manufacturer (Section D)
WALGREENS
MDR Report Key8381859
MDR Text Key137804601
Report NumberMW5084531
Device Sequence Number0
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 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberWGNSPS-960BT
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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