FDA.reportPublic FDA data

MAUDE MDR 1506329

MDR report key
1506329
Report number
2150060-2009-00153
Event key
0
Event type
3
Date of event
2009-09-10
Date received
2009-10-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GINNY STAMBERGER
Address
33 TECHNOLOGY DRIVE IRVINE CA 92618 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ASP AUTOMATIC ENDOSCOPE REPROCESSORAER EQUIPMENTMINNTECH CORP.NVENAAER387NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-10-070

Event Narratives#

D

Patient 1

THE CUSTOMER ALLEGED A CIDEX BRAND SOLUTION LEAK. DURING A WASH AND DISINFECT CYCLE, THE UNIT LEAKED CIDEX ONTO THE FLOOR. THE CUSTOMER COULD NOT TELL WHERE THE LEAK ORIGINATED. THERE WERE NO INJURIES INVOLVED ASSOCIATED WITH THE CIDEX LEAK. THE CUSTOMER CLEANED UP THE SOLUTION AND CHECKED TO MAKE SURE THE CYCLE COMPLETED PRIOR TO THE SYSTEM LEAK. THE CUSTOMER THEN PERFORMED A WASH AND DISINFECT CYCLE WITH WATER TO DETERMINE WHERE THE LEAK ORIGINATED. AT THIS TIME, NO INFO IS RECEIVED FROM THE CUSTOMER ON THE STATUS OF THE UNIT.