FDA Adverse Event
Malfunction
Summary report: N
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
MDR report key: 1386175
·
Received March 11, 2009
Report
- Report Number
- 2150060-2009-00020
- Event Type
- Malfunction
- Date Received
- March 11, 2009
- Date of Event
- February 25, 2009
- Report Date
- February 25, 2009
- Manufacturer
- MINNTECH CORPORATION
- 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
THE ACTUAL COMPONENT WAS EVALUATED AT THE CUSTOMER'S SITE. THE FSE REPLACED THE DRAIN VALVE. THE FSE RAN MULTIPLE TEST CYCLES WHILE MONITORING FLUID LEVELS IN THE DISINFECTANT RESERVOIR. THERE WAS NO RISE NOTICED ON THE RESERVOIR. AT THIS TIME, THE AER MEETS MANUFACTURER'S SPECIFICATIONS. UPON FOLLOW UP, THE CUSTOMER STATED THAT THEY WILL BE SWITCHING TO CIDEX OPA AS THEY ONLY NOTICED OVERFLOW ERRORS WHEN USING METRICIDE.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THEIR UNIT EXHIBITED AN OVERFLOW ERROR AND A DISINFECTANT LEAK. THERE WERE NO REPORTS OF INJURIES. THE 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 | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER | AER EQUIPMENT | NVE | MINNTECH CORPORATION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | OLYMPUS SCOPES| METRICIDE, LOT UNK |