FDA Adverse Event
Malfunction
Summary report: N
ASP AUTOMATIC ANDOSCOPE WITH PRINTER
MDR report key: 1396733
·
Received March 18, 2009
Report
- Report Number
- 2150060-2009-00037
- 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
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
OTHER: THE ACTUAL COMPONENT WAS EVALUATED AT CUSTOMER'S SITE. THE FSE REMOVED AND REPLACED V-1. THE FSE TIGHTENED ALL CONNECTIONS AND RAN TWO CYCLES.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING CIDEX OPA. 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 ANDOSCOPE WITH PRINTER | AER EQUIPMENT | NVE | MINNTECH CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | CATALOG 20390| CIDEX OPA |