AMSORB PLUS
Received Mar 31, 2020 · Event occurred Mar 11, 2020
Report 9902766 · MDR key 9902766
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vc/fda ConsultingModel number
AMAB3801Catalog number
AMAB3801
Lot number
210619F31
Product problems
- Component or Accessory Incompatibility
- Gas/Air Leak
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
DURING ROOM TURNOVER ANESTHESIA GAS MACHINE DID NOT PASS LEAK TEST. AFTER IN-SERVICING BIO-MED WAS CALLED. IT WAS NOTED BY BIO-MED REP THAT THE ENGINEERING ON THE AMSORB PLUS PRODUCT IS OFF BY 1MM ON THE GE MACHINE WHICH WAS CAUSING A SMALL LEAK TO BE DETECTED. AFTER RESEARCHING WE NOTED THAT SOME MACHINES WILL PICK UP THE LEAK AND SOME WILL NOT DUE TO THE MINUTE OFFSETTING. OUR CONCERN WAS IF THIS WAS TRANSPIRING IN OTHER FACILITIES BUT HAS NOT BEEN REPORTED DUE TO IT BEING CAUGHT BEFORE PATIENT IS ATTACHED TO MACHINE OR ANESTHESIA TECH NOT REALIZING IT IS AN ENGINEERING MALFUNCTION.