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

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.

• Brand Name: BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM MEASUREMENT BLOOD PRESSURE
• Manufacturer (Section D): WELCH ALLYN, INC.
• MDR Report Key: 7813003
• MDR Text Key: 118393004
• Report Number: MW5079363
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 72