OHIO MEDICAL

Additional Manufacturer Narrative

UPON RECEIVING MEDWATCH FORM 3500A, COMPLAINT CASE (B)(4) WAS INITIATED TO INVESTIGATE THE REPORTED INCIDENT INVOLVING THE OHIO MEDICAL INTEGRATED FLOWMETER (SERIAL #(B)(6)). UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE DEVICE IN QUESTION WAS A 15L OXYGEN STANDARD FLOWMETER, NOT AN INTEGRATED FLOWMETER AS INITIALLY INDICATED. THIS FLOWMETER WAS ORIGINALLY MANUFACTURED BY T-MEC, AN OUTSOURCED CONTRACTED MANUFACTURER, IN 2011. DURING THE EVALUATION, IT WAS CONFIRMED THAT THE TOP PORTION OF THE FLOWMETER HAD SUFFERED A BREAKAGE. A CRACK WAS OBSERVED ALONG THE RADIUS OF THE HOOD, WITH THE TOP OF THE DEVICE PEELING BACK. THIS ALLOWED THE O-RING AND BALL MECHANISM TO EJECT FROM THE DEVICE, WHICH CONTRIBUTED TO THE REPORTED SAFETY CONCERN. FURTHER INSPECTION INDICATED THAT THE MATERIAL MAY HAVE BEEN WEAKENED OVER TIME DUE TO EXPOSURE TO CLEANING SOLUTIONS, OR ALTERNATIVELY, THE DEVICE COULD HAVE BEEN DROPPED OR OTHERWISE IMPACTED, LEADING TO A WEAK SPOT DEVELOPING IN THE HOOD AREA. THE FLOWMETER ALSO DISPLAYED SIGNS OF MULTIPLE IMPACTS, AS EVIDENCED BY THE CONDITION OF THE LABEL, WHICH SUGGESTS THAT THE DEVICE HAD BEEN SUBJECTED TO VARIOUS FORMS OF USER ABUSE OR ROUGH HANDLING, RATHER THAN A MANUFACTURING DEFECT OR MATERIAL FAILURE. BASED ON THE FINDINGS, IT IS CONCLUDED THAT THE ROOT CAUSE OF THE INCIDENT WAS NOT A DEFECT IN THE MATERIAL OR MANUFACTURING PROCESS, BUT RATHER THE RESULT OF USER ABUSE AND EXTERNAL FACTORS CONTRIBUTING TO THE DAMAGE. ALTHOUGH THIS INCIDENT DID NOT RESULT IN HARM, THE RISK CLASSIFICATION WAS DETERMINED BASED ON THE REPORTING REQUIREMENT.

Description of Event or Problem

ON (B)(6) 2024, OHIO MEDICAL RECEIVED A MANDATORY AND VOLUNTARY REPORT (B)(4) FROM THE FOOD AND DRUG ADMINISTRATION (FDA). ACCORDING TO THE REPORT, THE EVENT OCCURRED ON (B)(6) 2024, IN (B)(6) LOCATED IN (B)(6), CA, REGARDING AN OHIO MEDICAL INTEGRATED FLOWMETER (SERIAL #(B)(6)). IN THE REPORT IT STATES THE FOLLOWING, "THE PATIENT WAS GOING TO BE PLACED ON A NON-REBREATHER MASK, AND IT WOULD APPEAR THAT THE OXYGEN FLOWMETER WAS MOVED FROM ONE O2 OUTLET TO ANOTHER. UPON MOVING THE O2 FLOWMETER TO ANOTHER O2 OUTLET, A PIECE OF THE GAS OUTLET TO THE MANIFOLD (TOP OF THE FLOWMETER) BROKE OFF, FLYING ACROSS THE ROOM AND ALMOST INJURING SOMEONE." THIS EVENT RAISES CONCERNS REGARDING THE DURABILITY, SAFETY, AND POTENTIAL DESIGN ISSUES WITH THE FLOWMETER'S ASSEMBLY, AS WELL AS THE POTENTIAL FOR SIMILAR INCIDENTS TO OCCUR IN OTHER MEDICAL FACILITIES USING THE SAME EQUIPMENT.

Additional Manufacturer Narrative

UPON RECEIVING MEDWATCH FORM 3500A, COMPLAINT CASE (B)(4) WAS INITIATED TO INVESTIGATE THE REPORTED INCIDENT INVOLVING THE OHIO MEDICAL INTEGRATED FLOWMETER (SERIAL # (B)(6). UPON FURTHER INSPECTION, IT WAS DETERMINED THAT THE DEVICE IN QUESTION WAS A 15L OXYGEN STANDARD FLOWMETER, NOT AN INTEGRATED FLOWMETER AS INITIALLY INDICATED. THIS FLOWMETER WAS ORIGINALLY MANUFACTURED BY T-MEC, AN OUTSOURCED CONTRACTED MANUFACTURER, IN 2011. DURING THE EVALUATION, IT WAS CONFIRMED THAT THE TOP PORTION OF THE FLOWMETER HAD SUFFERED A BREAKAGE. A CRACK WAS OBSERVED ALONG THE RADIUS OF THE HOOD, WITH THE TOP OF THE DEVICE PEELING BACK. THIS ALLOWED THE O-RING AND BALL MECHANISM TO EJECT FROM THE DEVICE, WHICH CONTRIBUTED TO THE REPORTED SAFETY CONCERN. FURTHER INSPECTION INDICATED THAT THE MATERIAL MAY HAVE BEEN WEAKENED OVER TIME DUE TO EXPOSURE TO CLEANING SOLUTIONS, OR ALTERNATIVELY, THE DEVICE COULD HAVE BEEN DROPPED OR OTHERWISE IMPACTED, LEADING TO A WEAK SPOT DEVELOPING IN THE HOOD AREA. THE FLOWMETER ALSO DISPLAYED SIGNS OF MULTIPLE IMPACTS, AS EVIDENCED BY THE CONDITION OF THE LABEL, WHICH SUGGESTS THAT THE DEVICE HAD BEEN SUBJECTED TO VARIOUS FORMS OF USER ABUSE OR ROUGH HANDLING, RATHER THAN A MANUFACTURING DEFECT OR MATERIAL FAILURE. BASED ON THE FINDINGS, IT IS CONCLUDED THAT THE ROOT CAUSE OF THE INCIDENT WAS NOT A DEFECT IN THE MATERIAL OR MANUFACTURING PROCESS, BUT RATHER THE RESULT OF USER ABUSE AND EXTERNAL FACTORS CONTRIBUTING TO THE DAMAGE. ALTHOUGH THIS INCIDENT DID NOT RESULT IN HARM, THE RISK CLASSIFICATION WAS DETERMINED BASED ON THE REPORTING REQUIREMENT.

Description of Event or Problem

ON OCTOBER 28, 2024, OHIO MEDICAL RECEIVED A MANDATORY AND VOLUNTARY REPORT (# (B)(4) FROM THE FOOD AND DRUG ADMINISTRATION (FDA). ACCORDING TO THE REPORT, THE EVENT OCCURRED ON MAY 1, 2024, IN (B)(6), REGARDING AN OHIO MEDICAL INTEGRATED FLOWMETER (SERIAL # (B)(6). IN THE REPORT IT STATES THE FOLLOWING, "THE PATIENT WAS GOING TO BE PLACED ON A NON-REBREATHER MASK, AND IT WOULD APPEAR THAT THE OXYGEN FLOWMETER WAS MOVED FROM ONE O2 OUTLET TO ANOTHER. UPON MOVING THE O2 FLOWMETER TO ANOTHER O2 OUTLET, A PIECE OF THE GAS OUTLET TO THE MANIFOLD (TOP OF THE FLOWMETER) BROKE OFF, FLYING ACROSS THE ROOM AND ALMOST INJURING SOMEONE." THIS EVENT RAISES CONCERNS REGARDING THE DURABILITY, SAFETY, AND POTENTIAL DESIGN ISSUES WITH THE FLOWMETER'S ASSEMBLY, AS WELL AS THE POTENTIAL FOR SIMILAR INCIDENTS TO OCCUR IN OTHER MEDICAL FACILITIES USING THE SAME EQUIPMENT.