InjuryCAX

MEDICAL GAS FLOWMETER

Received Aug 24, 2023 · Event occurred Aug 22, 2023

Report MW5144963 · MDR key 17624463

Device

Generic name

Flowmeter, Tube, Thorpe, Back-pressure Compensated

Manufacturer

Ohio Medical Llc

Model number

FM-15UO-F2

Patient

Unknown

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

Narrative

Description of Event or Problem

A BATCH OF 3000 THORPE TUBE FLOWMETERS WITH AMVEX BRAND FROM OHIO MEDICAL INC. WAS FOUND THAT APPROX 200 UNITS FROM THE BATCH ARE SERIOUS FALL OFF THE STANDARD ACCURACY REQUIREMENTS; (B)(4) UNITS ARE AT THE LOWER EDGE OF ACCURACY AND CONSIDER UNCERTAINTY RISK. WHICH RESULT OF 33% NONCONFORMITY PRODUCTS. THE TEST WAS CONTROL ACCORDING TO MANUFACTURER SPECIFICATION. 50PSI INPUT. CALIBRATED DIGITAL FLOWMETER.