FDA Adverse Event
Malfunction
Summary report: N
ALARIS SYSTEM
MDR report key: 12959137
·
Received December 8, 2021
Report
- Report Number
- 2016493-2021-75614
- Event Type
- Malfunction
- Date Received
- December 8, 2021
- Date of Event
- November 16, 2021
- Report Date
- December 31, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
OMIT : A070803 - FAILURE TO POWER UP (1476) , B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE.
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.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE NOT TURNING ON / OFF. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE NOT TURNING ON / OFF. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1861113 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |