ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-231691
- Event Type
- Malfunction
- Date Received
- November 29, 2022
- Date of Event
- November 10, 2022
- Report Date
- July 17, 2023
- Manufacturer
- CAREFUSION SD
- Product Code
- CCK
- UDI-DI
- 10885403830013
- PMA / PMN Number
- K031741
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PLEASE NOTE THAT THE INITIAL REPORT FOR MFR REPORT # 2016493-2022-231691 WAS SUBMITTED FOR THE ERROR CODE 571.6241 WHICH WAS OBSERVED DURING DEVICE SERVICING PROCESS. THIS FOLLOW-UP REPORT IS SUBMITTED TO ADD CLARITY TO THE PREVIOUS REPORT. ADDITIONAL IMDRF CODES ARE INCLUDED IN THIS FOLLOW-UP REPORT TO REFLECT THE OBSERVED ERROR CODE. CORRECTION: ANNEX A: A1205 ANNEX C: C07 ANNEX D: D15 ADDITIONAL INFORMATION: ANNEX A: A13. ANNEX C: C02. ANNEX D: D02.
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN THIS MDR REPORT.PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
IT WAS REPORTED THAT THE DEVICE SHOWS ORIDION OS: N/A AND DISPLAYED CHANNEL ERROR WHILE UNIT WAS FLASHING. ALSO, DEVICE HAD BEEN CONNECTED TO A BRAIN FOR 5MINUTES TO WARM UP THE SENSOR PRIOR FLASHING. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE SHOWS ORIDION OS: N/A AND DISPLAYED CHANNEL ERROR WHILE UNIT WAS FLASHING. ALSO, DEVICE HAD BEEN CONNECTED TO A BRAIN FOR 5MINUTES TO WARM UP THE SENSOR PRIOR FLASHING. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE DEVICE SHOWS ORIDION OS: N/A AND DISPLAYED CHANNEL ERROR WHILE UNIT WAS FLASHING. ALSO, DEVICE HAD BEEN CONNECTED TO A BRAIN FOR 5MINUTES TO WARM UP THE SENSOR PRIOR FLASHING. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1960192 | ALARIS SYSTEM | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | CCK | CAREFUSION SD | 8300 | 10885403830013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |