MAUDE Adverse Event Report: OMRON HEALTHCARE, INC. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number BP7100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

When validating the home blood pressure monitor, discovered cuff was reading inaccurate and gave a false elevated reading.

• Brand Name: OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): OMRON HEALTHCARE, INC.; 1925 west field court, suite' 100; lake forest IL 60045
• MDR Report Key: 11154034
• MDR Text Key: 226241761
• Report Number: 11154034
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BP7100
• Device Catalogue Number: BP7100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1