ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-27 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..

Event Text Entries

[1118440] The customer alleged there was no disinfectant solution in the basin during the wash and disinfect cycle. The customer was certain the disinfectant solution was in the reservoir prior. The customer later stated cidex opa solution leaked outside the unit and onto the floor. There were no injuries involved. An asp field service engineer (fse) went to the facility, performed an assessement, and repaired the unit.
Patient Sequence No: 1, Text Type: D, B5


[8362899] Equipment evaluated at the customer site. The fse arrived at the facility and found unit's reservoir was leaking around the heater element. The fse replaced the tank assembly and tested for leaks. The fse performed a test cycle then returned the unit to full operation. The fse reset the unit and had the customer enter the wash and disinfect cycle.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2150060-2009-00160
MDR Report Key1517153
Report Source05
Date Received2009-10-27
Date of Report2009-09-29
Date of Event2009-09-29
Date Mfgr Received2009-09-29
Date Added to Maude2009-11-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactGINNY STAMBERGER
Manufacturer Street33 TECHNOLOGY DR.
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9497893837
Manufacturer G1MINNTECH CORP.
Manufacturer Street14605 28TH AVE. NORTH
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
Generic NameAER EQUIPMENT
Product CodeNVE
Date Received2009-10-27
Model NumberNA
Catalog Number20301
Lot NumberNA
ID NumberPART # : NA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMINNTECH CORP.
Manufacturer AddressMINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
10 2009-10-27

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