FDA Adverse Event
Malfunction
Summary report: N
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
MDR report key: 1395168
·
Received March 31, 2009
Report
- Report Number
- 2150060-2009-00047
- Event Type
- Malfunction
- Date Received
- March 31, 2009
- Date of Event
- March 2, 2009
- Report Date
- March 2, 2009
- Manufacturer
- MINNTECH CORP.
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REF MDR: 2150060-2009-00048, 8021896-2009-00010.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED TWO AER UNITS WERE LEAKING "GREEN FLUID" (CIDEX OPA) FROM UNDERNEATH. THE CUSTOMER STATED THAT NO INJURIES WERE INVOLVED. THE UNITS WERE NOT IN USE. THE CUSTOMER REQUESTED AN ASP FIELD SERVICE ENGINEER (FSE) TO EXAMINE THE UNITS.
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 | CIDEX OPA SOLUTION, UNK LOT |