FDA Adverse Event
Malfunction
Summary report: N
STERRAD NX STERILIZATION SYSTEM
MDR report key: 1003397
·
Received February 21, 2008
Report
- Report Number
- 2084725-2008-00014
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 24, 2008
- Report Date
- January 24, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- MLR
- PMA / PMN Number
- K042116
- Removal / Correction Number
- Z-1631-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FSE REPLACED THE OIL MIST FILTER. HE RAN A TEST CYCLE AND THE UNIT MET MFR SPECS.
Description of Event or Problem · 1
WHILE PERFORMING PREVENTATIVE MAINTENANCE THE ASP FIELD SVC ENGINEER (FSE) NOTED OIL MIST COMING FROM THE UNIT. THE CUSTOMER STATED THAT THEY WERE UNAWARE OF THE MIST AND THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE FSE REPAIRED THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD NX STERILIZATION SYSTEM | STERILIZER | MLR | ADVANCED STERILIZATION PRODUCTS | 10033 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |