FDA Adverse Event
Malfunction
Summary report: N
PYXIS ANESTHESIA SYSTEM (PAS)
MDR report key: 2240913
·
Received August 8, 2011
Report
- Report Number
- 2016493-2011-00081
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 21, 2011
- Manufacturer
- CAREFUSION
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL DATA/FAILURE INVESTIGATION. FIELD SERVICE TECHNICIAN INVESTIGATION DISCOVERED PHYSICAL ITEM OBSTRUCTION CAUSING DRAWER TO FAIL.
Description of Event or Problem · 1
CUSTOMER REPORTS DRAWER ON THE PYXIS ANESTHESIA SYSTEM FAILED. NO PT WAS PRESENT.
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 |