FDA.reportPublic FDA data

MAUDE MDR 9902766

MDR report key
9902766
Report number
9902766
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMSORB PLUSABSORBENT, CARBON-DIOXIDEVC/FDA CONSULTINGCBLAMAB3801AMAB3801210619F31* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

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.