FDA Adverse Event
Malfunction
Summary report: N
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
MDR report key: 1365304
·
Received March 6, 2009
Report
- Report Number
- 2150060-2009-00012
- Event Type
- Malfunction
- Date Received
- March 6, 2009
- Date of Event
- February 12, 2009
- Report Date
- February 12, 2009
- Manufacturer
- MINNTECH CORP.
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACTUAL COMPONENT EVALUATED AT CUSTOMER'S SITE. THE FSE REPLACED THE DISINFECT AND AIR VALVES DUE TO FLUID LEAK. THE FSE RAN MULTIPLE TEST CYCLES WHILE MONITORING FLUID LEVEL IN DISINFECT RESERVOIR. AT THIS TIME AER MEETS MFR SPECS.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING DISINFECTANT. THERE WERE NO REPORTS OF PHYSICAL INJURIES RELATED TO THE LEAK. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ACCESS THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER | AER EQUIPMENT | NVE | MINNTECH CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | METICIDE: LOT UNK |