FDA Adverse Event
Malfunction
Summary report: N
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
MDR report key: 1396736
·
Received March 18, 2009
Report
- Report Number
- 2150060-2009-00032
- Event Type
- Malfunction
- Date Received
- March 18, 2009
- Date of Event
- February 26, 2009
- Report Date
- February 26, 2009
- Manufacturer
- MINNTECH CORP.
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- Z-0281-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
OTHER: THE ACTUAL COMPONENT WAS EVALUATED AT THE CUSTOMER'S SITE. THE FSE CHECKED ALL CHANNELS: AIR PRESSURE IS APPROXIMATELY 19LBS. UPON FOLLOW-UP, THE CUSTOMER STATED THAT AN ASP CLINICAL EDUCATOR CONSULTANT (CEC) HAS ADVISED CUSTOMER TO FOLLOW PROPER PROCEDURES. THE CUSTOMER HAS NO FURTHER ISSUES WITH RESIDUALS. THE CUSTOMER ALSO STATED THAT THE SCOPES HAVE BEEN USED ON PATIENTS AFTER FOLLOWING RECOMMENDATIONS OF THE CEC, AND THERE HAS NOT BEEN ANY INJURIES OR COMPLICATIONS.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT RESIDUAL CIDEX BLOWS OUT OF THEIR OLYMPUS SCOPES AFTER PROCESSING. THE AP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS 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 | UNKNOW CIDEX |