MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-04 for PYXIS ANESTHESIA SYSTEM (PAS) 4000 manufactured by Carefusion.
[21561999]
Customer did observe a small amount of smoke from the device during refill. There was no fire or sparking observed. There was no patient present in the room and no ongoing or pending case. No harm to any user.
Patient Sequence No: 1, Text Type: D, B5
[21709504]
(b)(4). Field service technician investigated device and found the rear controller board that there was a small burn mark around a transistor. The board was replaced and all tested normal. Part in route to carefusion for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016493-2015-00457 |
| MDR Report Key | 4818851 |
| Report Source | 07 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-05-06 |
| Date Mfgr Received | 2015-05-06 |
| Date Added to Maude | 2015-07-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CHIP IVERSON |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214386 |
| Manufacturer Phone | 8586172000 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 92121438 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 4386 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYXIS ANESTHESIA SYSTEM (PAS) |
| Generic Name | AUTOMATED DISPENSING CABINET (ADC'S) |
| Product Code | BRY |
| Date Received | 2015-06-04 |
| Model Number | 4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 92121438 US 92121 4386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |