FDA.reportPublic FDA data

MAUDE MDR 7824005

MDR report key
7824005
Report number
7824005
Event key
0
Event type
3
Date of event
2018-08-15
Date received
2018-08-28
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
401
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
1VITAL SIGNS ADULT BREATHING CIRCUITANESTHESIA BREATHING CIRCUITCAREFUSIONBSJA5U510X4A5U510X40004033682* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-280

Event Narratives#

D

Patient 1

DURING THE DAILY ANESTHESIA AUTOMATED PERFORMANCE TESTING, THE ANESTHESIA MACHINE FAILED BREATHING CIRCUIT LEAK TEST. TROUBLESHOOTING BY THE BIO-MEDICAL ENGINEERING TECHNICIAN (BMET) NOTED THAT WHEN 3 LITER BREATHING BAG WAS CONNECTED DURING LEAK TEST THE SYSTEM WOULD FAIL PRE-OPERATIVE LEAK TEST. THE BMET REPLACED THE BREATHING BAG WITH A SILICON TEST PLUG AND THE LEAK SELF TEST PASSED. WHEN 3 LITER BAG WAS PLACED ON SEPARATE 22MM BAG ARM CONNECTOR THE BMET VALIDATED THAT THE BAG CONNECTOR WOULD NOT HOLD PRESSURE AND WOULD LEAK. SEVERAL BREATHING BAGS WERE TESTED WITH SIMILAR RESULTS, SOME WITH MORE SIGNIFICANT LEAKS THAN OTHERS. THE BREATHING BAGS ARE A COMPONENT PART OF A SINGLE PATIENT USE ANESTHESIA BREATHING CIRCUIT.