FDA Adverse Event
Malfunction
Summary report: N
AUTOMATIC ENDOSCOPE REPROCESSOR
MDR report key: 1355631
·
Received February 25, 2009
Report
- Report Number
- 2084725-2009-00123
- Event Type
- Malfunction
- Date Received
- February 25, 2009
- Date of Event
- January 29, 2009
- Report Date
- January 29, 2009
- Manufacturer
- UNITROL/MINNTECH COR
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OTHER - THE CUSTOMER REPAIRED THE UNIT. THE CUSTOMER REMOVED THE RELIEF VALVE CLEANED IT, AND PUT IT BACK ON AND SO FAR THERE HAS NOT BEEN ANY MORE LEAKS.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING CIDEX. THERE WERE NO REPORTS OF INJURIES RELATED TO THE LEAK. THE CUSTOMER REPAIRED THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOMATIC ENDOSCOPE REPROCESSOR | AER EQUIPMENT | NVE | UNITROL/MINNTECH COR | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | UNK CIDEX |