• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN, INC. BLOOD PRESSURE MONITOR SYSTEM MEASUREMENT BLOOD PRESSURE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WELCH ALLYN, INC. BLOOD PRESSURE MONITOR SYSTEM MEASUREMENT BLOOD PRESSURE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2018
Event Type  No Answer Provided  
Event Description
My blood pressure machine and scale to measure my weight is giving me inaccurate readings.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBLOOD PRESSURE MONITOR
Type of DeviceSYSTEM MEASUREMENT BLOOD PRESSURE
Manufacturer (Section D)
WELCH ALLYN, INC.
MDR Report Key7813003
MDR Text Key118393004
Report NumberMW5079363
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 08/23/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/23/2018
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 08/23/2018 Patient Sequence Number: 1
-
-