FDA Adverse Event
Malfunction
Summary report: N
PYXIS ANESTHESIA SYSTEM (PAS)
MDR report key: 21161733
·
Received January 15, 2025
Report
- Report Number
- 2016493-2025-01141
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 18, 2024
- Report Date
- January 16, 2025
- Manufacturer
- CAREFUSION 303
- Product Code
- BRY
- UDI-DI
- 10885403477836
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DEVICE HAD A FAILED HARD DRIVE. THE FIELD SERVICE ENGINEER REPLACE HARD DRIVE, BEGAN INSTALLATION, FOUND THAT DHA FILES WERE OUT OF DATE/CORRUPTED. THE FSE PERFORMED DHA HARD DRIVE SWAP AND INSTALL TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA SYSTEM HAD A COMMUNICATION ISSUE. THE CUSTOMER STATED THAT THE DEVICE IS NOT COMMUNICATING, BLACK SCREEN AND ASKING FOR PASSWORD. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1300045 | PYXIS ANESTHESIA SYSTEM (PAS) | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303 | 327 | 10885403477836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |