FDA Adverse Event
Malfunction
Summary report: N
ALARIS PC UNIT
MDR report key: 10793384
·
Received November 5, 2020
Report
- Report Number
- 2016493-2020-34229
- Event Type
- Malfunction
- Date Received
- November 5, 2020
- Report Date
- October 1, 2020
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM 12/04/2012 TO 10/28/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE ONE TIME WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIRS. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1258140 | ALARIS PC UNIT | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |