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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOOD PRESSURE MACHINE SYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE

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BLOOD PRESSURE MACHINE SYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE Back to Search Results
Device Problems Material Discolored (1170); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
Changed pharmacies - "different" color and "shape". Also blood pressure readings not taken correctly.
 
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Brand NameBLOOD PRESSURE MACHINE
Type of DeviceSYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE
MDR Report Key9134827
MDR Text Key160715517
Report NumberMW5090104
Device Sequence Number1
Product Code DXN
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/20/2019
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
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
Is This a Reprocessed and Reused Single-Use Device?

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