inforMED
MalfunctionPXE

PORTEX CUFF INFLATOR PRESSURE GAUGE

Received Apr 22, 2022

Report 3012307300-2022-06851 · MDR key 14186715

Device

Generic name

Pressure Monitoring (air/gas) Kit

Catalog number

100/568/000

Product problems

  • Pressure Problem
  • Pressure Problem

Patient

Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PARAMETERS ARE INCORRECT OF WHERE THE CUFF PRESSURE SHOULD BE. NO PATIENT INVOLVEMENT

Remedial action

  • Recall