FDA Adverse Event
Malfunction
Summary report: N
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
MDR report key: 1396739
·
Received March 18, 2009
Report
- Report Number
- 2150060-2009-00043
- Event Type
- Malfunction
- Date Received
- March 18, 2009
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- MINNTECH CORP.
- Product Code
- NVE
- PMA / PMN Number
- K832458
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: ASP ASSESSMENT: A REVIEW OF THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA) FOR ASP AER INDICATES FOR ALL RELATED FAILURE MODES THE OVERALL RISK NUMBER (RPM) ASSOCIATED WITH LEAKAGE ARE ALL BELOW THE THRESHOLD OF 100, THEREFORE NO FURTHER ACTION IS REQUIRED AT THIS TIME. ASP WILL CONTINUE TO MONITOR FOR TRENDS. THIS COMPLAINT WAS PART OF A RETROSPECTIVE REVIEW CONDUCTED BY ASP.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING FLUID. THERE WERE NO REPORTS OF INJURIES.
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 | UNK FLUID| UNK FLUID |