MalfunctionCCM
MGC DIAGNOSTICS
Received Nov 3, 2020 · Event occurred Jul 16, 2020
Report 10778673 · MDR key 10778673
Device
Generic name
Plethysmograph, Pressure
Model number
830008-902Product problems
- Failure to Calibrate
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHILE THE PULMONARY FUNCTION TECHNOLOGIST (PFT), TECHNOLOGIST ATTEMPTED TO CALIBRATE THE DEVICE USING A CALIBRATED TEST SYRINGE IT FAILED TO CALIBRATE. MANUFACTURER RESPONSE FOR PLETHYSMOGRAPH, BODY, PLATINUM ELITE RDX (PER SITE REPORTER). PLEASE REPLACE THE FLOW BOARD.