OHIO MEDICAL

Additional Manufacturer Narrative

AN EXTERNAL CLINICAL REPRESENTATIVE, (B)(6), MS, RRT-ACCS, DIRECTOR OF CLINICAL EDUCATION - RESPIRATORY PROGRAM AT OZARKS TECHNICAL COMMUNITY COLLEGE WAS CONTACTED ON APRIL 28, 2021. HE EXPLAINED THAT DEPENDING ON THE BIPAP MODELS, INLET FLOW MAY BE RESTRICTED. HE WAS UNSURE WHY A FLOWMETER WOULD BE INSTALLED IN COMBINATION WITH A BIPAP MACHINE. TO DATE WE HAVE BEEN UNABLE TO GET THE MANUFACTURER/MODEL OF ACTUAL BIPAP MODEL THAT WAS IN USE AT THE TIME OF THE ALLEGED FLOWMETER MALFUNCTION. ENVIRONMENTAL VARIABLES (E.G., MOISTURE, STATIC, ANGLE OF THE FLOWMETER WHEN INSTALLED) COULD IMPACT THE LEVEL THAT THE FLOWMETER IS READING. OHIO MEDICAL REQUESTED ADDITIONAL INFORMATION FROM THE ORIGINAL REPORTER. FOLLOW-UP PHONE CALLS AND EMAILS WERE UNABLE TO DETERMINE ANY CONTRIBUTING FACTORS TO THE ALLEGED FAILURE. A REVIEW OF THE INSTRUCTIONS FOR USE AND SERVICE MANUAL CONFIRMED TROUBLE SHOOTING STEPS ARE IDENTIFIED FOR THIS POSSIBLE MALFUNCTION. THIS DEVICE WAS ORIGINALLY SHIPPED IN MARCH OF 2008. ORIGINAL DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES NOTED. DEVICE WAS RETURNED ON MAY 3, 2021 AND EVALUATED BY ENGINEERING. FLOW ACCURACY WAS CONFIRMED TO BE WITHIN SPECIFICATION, AND THERE WERE NO ANOMALIES NOTED.

Description of Event or Problem

COMPLAINT (B)(4) WAS RECEIVED DIRECTLY FROM USER FACILITY ON APRIL 8, 2021 ALLEGING A DEVICE MALFUNCTION WITH AN OHIO MEDICAL FLOWMETER. ORIGINAL COMPLAINT STATED: PATIENT WAS ON BI-PAP WITH BLEED IN 02 SEVERE COPD WITH DESAT'S INTO THE 70'S NEEDING INTERVENTIONS TO SWITCH 02 SOURCES TO STABILIZE PATIENT. THE MINOR SHORT TERM DESATURATION CAUSED DELAY IN TREATMENT UNTIL OXYGEN SOURCE WAS CHANGED. DEATH, ILLNESS OR SERIOUS INJURY DID NOT OCCUR. MEDWATCH 3500A REPORT (B)(4) FOR SAME ALLEGED MALFUNCTION WAS THEN RECEIVED VIA (B)(6) ON APRIL 27, 2021. THE MEDWATCH REPORT ADDED THAT THE FLOW WAS NOT READING ACCURATELY, AS THE FLOWMETER WAS READING AS 15 LITERS PER MINUTE (LPM) BUT THERE WAS NO OXYGEN BEING DELIVERED.