MEDISORB¿ EX, DISPOSABLE
Received Aug 23, 2019 · Event occurred Jul 29, 2019
Report 3002807637-2019-00001 · MDR key 8928173
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
H10 COMMENT: THE SAMPLE PHOTO WAS ANALYZED AND NO FAILURE WAS DETECTED. A DEVICE HISTORY RECORD (DHR) OF THE LOT NUMBER REVEALED NO ISSUES. A ROOT CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
VYAIRE HAS RECEIVED PHOTOS OF THE SAMPLE FOR THE INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE OR IF WE RECEIVE ANY ADDITIONAL INFORMATION WE WILL PROVIDE A FOLLOW UP EMDR.
Description of Event or Problem
A CUSTOMER CONTACTED VYAIRE MEDICAL TO REPORT A CRACKED SODALIME CANISTER THAT HAD A LEAK IN THE CIRCUIT NOTED DURING USE ON A PATIENT. CUSTOMER EXPLAINED THAT SODA LIME WAS ATTACHED TO THE MACHINE, BUT AS SOON AS THE MACHINE TRIED TO VENTILATE THE PATIENT, THE BELLOWS WOULD NOT FILL. THIS RESULTED IN FAILURE TO VENTILATE THE PATIENT APPROPRIATELY BUT WAS QUICKLY RECTIFIED. PATIENT WAS HAND VENTILATED. NO HARM CAME TO THE PATIENT.