VENTLAB

Description of Event or Problem

THE RED FITS-ALL O2 CONNECTION DOES NOT TIGHTLY FIT AROUND THE BUBBLE CONNECTION ON THE FLOW ELIMINATOR.

Additional Manufacturer Narrative

THE RED FITS-ALL O2 CONNECTION DOES NOT TIGHTLY FIT AROUND THE BUBBLE CONNECTION ON THE FLOW ELIMINATION DURING RESUSCITATION WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED. PRODUCT NOT RETURNED, NO IMAGES OF THE ISSUE ARE PROVIDED. COMPLAINT WAS STATED AS THE FITS-ALL CONNECTOR WAS NOT SECURE, THIS IS NOT CONFIRMED. HOWEVER, REPLACEMENT INVENTORY WAS PROVIDED. DESIGN HISTORY RECORD AND INVENTORY CANNOT BE REVIEWED WITHOUT A LOT NUMBER. IN THE PAST 24 MONTHS, THERE HAVE BEEN 0 COMPLAINTS RELATED. RMA-20020, FOR STEP R48 STATES, "PRODUCT NOT USED PROPERLY BY USER MAY LED TO IMPROPER FUNCTION OF THE DEVICE.", CAUSATION BEING "USER ERROR- USER DOES NOT CHECK FOR PROPER FUNCTION BEFORE USE." S=8, O=2, RPN=16, RC=1. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IT IS LIKELY THIS DESIGN WAS NOT BEING APPLIED CORRECTLY TO THE OTHER COMPANY'S DESIGN. THE FITS-ALL CONNECTOR, ALSO REFERRED TO AS UNIVERSAL CONNECTOR, U-CONNECT, TREAD GRIP CONNECTOR, ARE DESIGNED TO EITHER SCREW ONTO OXYGEN DISS 1240 FITTING OR A ¼" (5-7 MM) TAPERED FITTING. THIS TUBING CAN BE USED ON DEVICE THAT HAS SUPPLE TUBING-- NEBULIZER, RESUSCITATIONS BAGS, SAFETY-T, OXYGEN CANNULAS, OXYGEN MASK- ETC. ACCORDING TO THE USER GUIDE (UG-20044-C1) IN THEIR SITUATION OF NOT ATTACHING TIGHTLY THEY SHOULD HAVE USED THIS CONNECTOR RATHER THAN THE RIBBED END CONNECTOR. **UDI RELATED DATA QUALITY UPDATES ONLY**

Additional Manufacturer Narrative

THE RED FITS-ALL O2 CONNECTION DOES NOT TIGHTLY FIT AROUND THE BUBBLE CONNECTION ON THE FLOW ELIMINATION DURING RESUSCITATION WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED

Description of Event or Problem

THE RED FITS-ALL O2 CONNECTION DOES NOT TIGHTLY FIT AROUND THE BUBBLE CONNECTION ON THE FLOW ELIMINATOR

Additional Manufacturer Narrative

THE RED FITS-ALL O2 CONNECTION DOES NOT TIGHTLY FIT AROUND THE BUBBLE CONNECTION ON THE FLOW ELIMINATION DURING RESUSCITATION WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED PRODUCT NOT RETURNED, NO IMAGES OF THE ISSUE ARE PROVIDED. COMPLAINT WAS STATED AS THE FITS-ALL CONNECTOR WAS NOT SECURE, THIS IS NOT CONFIRMED. HOWEVER, REPLACEMENT INVENTORY WAS PROVIDED. DESIGN HISTORY RECORD AND INVENTORY CANNOT BE REVIEWED WITHOUT A LOT NUMBER. IN THE PAST 24 MONTHS, THERE HAVE BEEN 0 COMPLAINTS RELATED. RMA-20020, FOR STEP R48 STATES, "PRODUCT NOT USED PROPERLY BY USER MAY LED TO IMPROPER FUNCTION OF THE DEVICE.", CAUSATION BEING "USER ERROR- USER DOES NOT CHECK FOR PROPER FUNCTION BEFORE USE." S=8, O=2, RPN=16, RC=1. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IT IS LIKELY THIS DESIGN WAS NOT BEING APPLIED CORRECTLY TO THE OTHER COMPANY'S DESIGN. THE FITS-ALL CONNECTOR, ALSO REFERRED TO AS UNIVERSAL CONNECTOR, U-CONNECT, TREAD GRIP CONNECTOR, ARE DESIGNED TO EITHER SCREW ONTO OXYGEN DISS 1240 FITTING OR A ¼" (5-7 MM) TAPERED FITTING. THIS TUBING CAN BE USED ON DEVICE THAT HAS SUPPLE TUBING-- NEBULIZER, RESUSCITATIONS BAGS, SAFETY-T, OXYGEN CANNULAS, OXYGEN MASK- ETC. ACCORDING TO THE USER GUIDE (UG-20044-C1) IN THEIR SITUATION OF NOT ATTACHING TIGHTLY THEY SHOULD HAVE USED THIS CONNECTOR RATHER THAN THE RIBBED END CONNECTOR.

Description of Event or Problem

THE RED FITS-ALL O2 CONNECTION DOES NOT TIGHTLY FIT AROUND THE BUBBLE CONNECTION ON THE FLOW ELIMINATOR.