FDA Adverse Event
Malfunction
Summary report: N
STERRAD NX STERILIZER
MDR report key: 1060779
·
Received June 12, 2008
Report
- Report Number
- 2084725-2008-00285
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- May 5, 2008
- Report Date
- May 22, 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
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FIELD ENGINEER REPLACED THE OIL MIST FILTER. SINCE THE FILTER WAS REPLACED, THE CUSTOMER HAS EXPERIENCED NO ONGOING PROBLEMS. THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE UNIT EXPERIENCED ONE WEEK OF A HEAVY MIST IN THEIR STERILIZING DEPARTMENT. THE CUSTOMER REPORTED THAT ONE OF THE EMPLOYEES EXPERIENCED HEADACHE. THE CUSTOMER DID NOT SEE A DOCTOR OR REQUIRE TREATMENT FOR THE SYMPTOM. FIELD ENGINEER WENT TO THE FACILITY AND ASSESSED THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD NX STERILIZER | STERRAD EQUIPMENT (MLR) | MLR | ADVANCED STERILIZATION PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |