FDA Adverse Event
Malfunction
Summary report: N
STRYKER SLCD12
MDR report key: 18485754
·
Received January 10, 2024
Report
- Report Number
- 3013145340-2023-00012
- Event Type
- Malfunction
- Date Received
- January 10, 2024
- Date of Event
- June 1, 2022
- Report Date
- December 29, 2023
- Manufacturer
- TERRAGENE S.A
- Product Code
- FRC
- UDI-DI
- 07798164678175
- PMA / PMN Number
- K191021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO DEVICE-RELATED DEATH OR SERIOUS INJURY WAS REPORTED. THE POSITIVE READOUT MAY HAVE BEEN CAUSED BY AN INEFFECTIVE STERILIZATION PROCESS. HOWEVER, AS NO FURTHER INFORMATION WAS PROVIDED, WE CONSIDER THERE'S A POSSIBILITY OF BI MALFUNCTION, WHICH MAY CAUSE THE DEVICE TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISE THE STERILIZATION PROCESS MONITORING EFFECTIVENESS WHICH COULD CONTRIBUTE TO DELAY PATIENT TREATMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WERE RECURRING BIS FOLLOWING COMPLETED VP4 CYCLES. THE VP4 DID NOT REGISTER ANY ERROR CODES OR CANCEL ANY LOADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1251706 | STRYKER SLCD12 | INCUBATOR | FRC | TERRAGENE S.A | STRYKER SLCD12 | SLCD124820 | 07798164678175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |