FDA Adverse Event
Other
Summary report: N
PYXIS ANESTHESIA SYSTEM (PAS)
MDR report key: 2849232
·
Received November 21, 2012
Report
- Report Number
- 2016493-2012-00005
- Event Type
- Other
- Date Received
- November 21, 2012
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- CAREFUSION
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL DATA / FAILURE INVESTIGATION. CAUSE OF FAILURE IS DETERMINED TO BE CUSTOMER CAUSED. CUSTOMER SPILLED IV FLUIDS ONTO THE UPS POWER SUPPLY, WHICH INGRESSED INTO THE ELECTRICAL COMPONENTS.
Description of Event or Problem · 1
CUSTOMER REPORT OF SMOKE FROM THE UPS POWER SUPPLY ON THE PAS DEVICE. CUSTOMER DENIES OBSERVING ANY SPARK OR FLAME. PATIENT WAS PRESENT. THERE WAS NO HARM TO THE PATIENT OR ANY USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PYXIS ANESTHESIA SYSTEM (PAS) | AUTOMATED DISPENSING CABINET (ADC'S) | BRY | CAREFUSION | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |