FDA Adverse Event
Malfunction
Summary report: N
STERRAD 100NX STERILIZER
MDR report key: 1213699
·
Received October 23, 2008
Report
- Report Number
- 2084725-2008-00682
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- March 22, 2008
- Report Date
- March 22, 2008
- Manufacturer
- JABIL
- Product Code
- MLR
- PMA / PMN Number
- K071385
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(OTHER, OIL MIST): THE SYSTEM HAS BEEN RETURNED TO ASP. A PRODUCT ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE AFFILIATES REPORTED THAT A STERRAD 100NX WAS SUPPLIED BY ASP FOR SALES FORCE TRAINING AND ELECTRICAL CERTIFICATION. THE SYSTEM WAS STARTED ONCE DURING TRAINING AND SHUT DOWN IMMEDIATELY WHEN IT WAS NOTICED THAT THE OIL MIST FILTER WAS NOT WORKING. THE SYSTEM WAS NEVER INTENDED FOR USE AT A CUSTOMER SITE AND HAS NEVER BEEN USED AT ANY CUSTOMER SITE. THE AFFILIATES REPORTED THAT THERE WERE NO ADVERSE REACTION NOTED. THE SYSTEM WAS RETURNED TO ASP FOR FURTHER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD 100NX STERILIZER | STERILIZER, CHEMICAL | MLR | JABIL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |