D
Patient 1
MAUDE MDR 1511038
- MDR report key
- 1511038
- Report number
- 2150060-2009-00157
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-09-18
- Date received
- 2009-10-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER | AER EQUIPMENT | MINNTECH CORP. | NVE | NA | 20301 | NA | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-10-13 | 0 |
Event Narratives#
N
Patient 1
ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A SERVICE HISTORY REVIEW, DEVICE HISTORY RECORD, COMPLAINT TRENDING BY PROBLEM, FAILURE MODE, AND EFFECTS ANALYSES, SYSTEM HAZARD AND USER MISUSE ANALYSIS, AND HEALTH HAZARD EVALUATION. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR THE AER (AUTOMATIC ENDOSCOPE REPROCESSOR) SHOWS THAT THE FINISHED PRODUCT MET MANUFACTURER'S SPECIFICATIONS AND PASSED ALL TESTS AT THE TIME OF RELEASE. A REVIEW OF THE SERVICE HISTORY FOR SIX MONTHS PRIOR TO THIS ISSUE, FROM (B)(4) 2009 THROUGH (B)(4) 2009, SHOWS A TREND WITH THE UNIT LEAKING MORE THAN A MAXIMUM OF THREE TIMES. HOWEVER, THERE IS NO TREND WITH THE REPLACED PARTS. THE AER CPUY (COMPLAINTS PER UNIT YEAR) TREND FOR PROBLEM "FLUID LEAK" FROM (B)(4) 2009 TO (B)(4) 2010, WAS COMPLETED. THE TREND LINE IS BELOW THE UCL (UPPER CONTROL LIMIT) FOR ALL TWELVE MONTHS. THE TREND IS NOT SIGNIFICANT OVERALL. THE AER FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND THE RPNS (RISK PRIORITY NUMBERS) DUE TO FAILURES TO THE UNIT ARE BELOW 100 AND ARE CONSIDERED LOW RISK FOR THIS UNIT. AN ASSESSMENT OF THE CIDEX OPA SOLUTION FMEA (FAILURE MODE AND EFFECTS ANALYSIS)) REVEALED THE RISK PRIORITY NUMBER (RPN) FOR SPILLS/ LEAKS IS BELOW THE THRESHOLD OF 100, INDICATING THAT THE ASSOCIATED RISK IS MINIMAL. THE CIDEX OPA SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WAS REVIEWED AND IT WAS DETERMINED THAT THE RISKS ASSOCIATED WITH CIDEX SPILLS ARE ALL CATEGORY I; THEREFORE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE CONCOMITANT PRODUCT IS A COMBINATION OF CIDEX DISINFECTANT AND WATER. NO FURTHER ACTIONS ARE REQUIRED FOR THIS ISSUE.
D
Patient 1
THE CUSTOMER ALLEGED, THE UNIT STOPPED IN THE MIDDLE OF A CYCLE AND DID NOT START BACK UP. THE UNIT WAS LEAKING A SMALL AMOUNT OF CIDEX BRAND SOLUTION FROM THE BOTTOM RIGHT-HAND CORNER. THE CUSTOMER REBOOTED THE UNIT, THE CONTROL PANEL STOP LIGHT CAME ON, BUT THE UNIT DID NOT START. THE CUSTOMER CLEANED UP THE LEAK. NO INJURIES OR ADVERSE EVENTS WERE INVOLVED. A FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.
N
Patient 1
THE VENDOR EVALUATED AT THE CUSTOMER'S SITE. THE FIELD SERVICE ENGINEER (FSE) FOUND THE CONTROL PANEL WAS NOT RESPONDING. THE FSE REPLACED IT AND PROVIDED THE CUSTOMER WITH A WRENCH FOR THE FILTER REPLACEMENT. DURING THE INSPECTION, THE FSE DETERMINED LEAKS THROUGHOUT THE UNIT CAUSED BY EXTERNAL FACTORS: THE CUSTOMER HAD FACILITY ISSUES THAT RESULTED IN EXCESSIVE HOT WATER RUNNING THROUGH THE UNIT. THE EXCESSIVE HEAT CAUSED WARPING OF THE VALVE STEMS RESULTING IN LEAKS FROM THE MANIFOLD AND INLET VALVE. AT THIS TIME, THE CUSTOMER HAS NOT COME TO A DECISION ON WHETHER TO REPAIR THE UNIT OR NOT. THE UNIT IS NOT IN USE.