FDA Adverse Event
Malfunction
Summary report: N
STERRAD 100S STERILIZATION SYSTEM
MDR report key: 1052323
·
Received May 22, 2008
Report
- Report Number
- 2084725-2008-00201
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 24, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- MLR
- PMA / PMN Number
- K991999
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CAPTIAL EQUIPMENT, THE FSE WENT TO THE FACILITY. THE FSE FOUND THE VAPORIZER PLATE MISSING. HE INSTALLED A VAPORIZER PLATE AND LEFT AN EXTRA FOR THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN EMPLOYEE WITH HYDROGEN PEROXIDE CONTACT AFTER A COMPLETED CYCLE. THE EMPLOYEE REPORTED SKIN DISCOLORATION AND DISCOMFORT AT THE CONTACT SITE ON HER FINGER. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. THE EMPLOYEE RINSED THE CONTACT AREA WITH WATER FOR 15 MINUTES. 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 | STERRAD 100S STERILIZATION SYSTEM | STERILIZER | MLR | ADVANCED STERILIZATION PRODUCTS | 10101 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |