inforMED
MalfunctionDXN

OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR

Received Apr 22, 2021 · Event occurred Apr 12, 2021

Report 11705846 · MDR key 11705846

Device

Generic name

System, Measurement, Blood-pressure, Non-invasive

Model number

BP7100

Catalog number

BP7100

Product problems

  • High Readings

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DEVICE IS READING >10MMHG HIGHER THAN BLOOD PRESSURE CHECKED AGAINST HOSPITAL MONITOR. DEVICE TAKEN OUT OF SERVICE AND NEW DEVICE GIVEN TO PATIENT.