inforMED
MalfunctionCCM

MGC DIAGNOSTICS

Received Nov 3, 2020 · Event occurred Sep 18, 2020

Report 10778671 · MDR key 10778671

Device

Generic name

Plethysmograph, Pressure

Model number

830008-902

Product problems

  • Calibration Problem

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

WHEN THE RESPIRATORY TECHNOLOGIST ATTEMPTED TO USE THE PFT ON A PATIENT IT FAILED TO CALIBRATE.