FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 13174026
·
Received January 6, 2022
Report
- Report Number
- 2016493-2021-79045
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- December 16, 2021
- Report Date
- January 7, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: IMDRF ANNEX A,B,G,C AND D GRIDS. OMIT: A070803 - FAILURE TO POWER UP (1476), G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE HAD WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738967 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |