FDA Adverse Event
Malfunction
Summary report: N
AUTOMATIC ENDOSCOPE REPROCESSOR
MDR report key: 1316435
·
Received February 18, 2009
Report
- Report Number
- 2084725-2009-00098
- Event Type
- Malfunction
- Date Received
- February 18, 2009
- Date of Event
- January 19, 2009
- Report Date
- January 19, 2009
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPORTED THE FOLLOWING: REPLACED THE DRAIN VALVE AND THE MAIN PUMP VALVE. THE FSE VERIFIED THAT THERE WAS NO LOSS OF DISINFECTANT. THE FSE PERFORMED SUCCESSFUL WASH/DISINFECT CYCLE.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THE UNIT WAS LOSING CIDEX BUT WAS NOT VISIBLE. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS RELATED TO THE CIDEX LEAK. AN ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOMATIC ENDOSCOPE REPROCESSOR | AER EQUIPMENT | NVE | ADVANCED STERILIZATION PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | CIDEX SOLUTION |