FDA.reportPublic FDA data

MAUDE MDR 1556456

MDR report key
1556456
Report number
2150060-2009-00169
Event key
0
Event type
3
Date of event
2009-11-09
Date received
2009-12-04
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 TECH. DR. 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 REPROCESSOR WITH PRINTERAER EQUIPMENTMINNTECH CORP.NVENA20301NAN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-040

Event Narratives#

D

Patient 1

THE CUSTOMER ALLEGED AN EO5 MESSAGE, AND THE UNIT WAS LEAKING. ADVANCED STERILIZATION PRODUCTS (ASP) ADVISED THE CUSTOMER TO CHECK FOR KINKS IN THE HOSES AND ANY BLOCKAGES. THE CUSTOMER DISCOVERED A PUDDLE OF "BLUE" SOLUTION ON THE FLOOR UNDER THE UNIT; NO LEAK WAS VISIBLE FROM THE UNIT. ASP LATER CONTACTED THE CUSTOMER, SHE STATED THE UNIT LEAKED CIDEX OPA SOLUTION ONTO THE FLOOR. NO INJURIES WERE INVOLVED. THE CUSTOMER INCORRECTLY POSITIONED THE FLOAT SWITCH; THE FLOAT SWITCH WAS REPOSITIONED CORRECTLY. THE CUSTOMER DID NOT NEED SERVICE AND CANCELLED THE REQUEST. THE UNIT IS CURRENTLY IN OPERATION.

N

Patient 1

CAPITAL EQUIPMENT EVALUATED AT THE CUSTOMER SITE. THE CUSTOMER REPOSITIONED THE FLOAT SWITCH TO RESOLVE THE ISSUE. METHOD - CUSTOMER REPAIRED THE UNIT. RESULT: FLOAT SWITCH.