MalfunctionDXN
OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR
Received Jan 12, 2021 · Event occurred Nov 2, 2020
Report 11154034 · MDR key 11154034
Device
Generic name
System, Measurement, Blood-pressure, Non-invasive
Manufacturer
Omron Healthcare, Inc.Model number
BP7100Catalog number
BP7100
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHEN VALIDATING THE HOME BLOOD PRESSURE MONITOR, DISCOVERED CUFF WAS READING INACCURATE AND GAVE A FALSE ELEVATED READING.