MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07,company representative, report with the FDA on 2015-06-04 for PYXIS ANESTHESIA SYSTEM (PAS) 3500 manufactured by Carefusion.
[17218214]
Customer reported seeing smoke from the pyxis anesthesia device. No patient or user was harmed.
Patient Sequence No: 1, Text Type: D, B5
[17430714]
(b)(4). (b)(4). Additional data / failure investigation customer reported liquid spill to the rear of the pas device while in use. Customer reported observed seeing electrical smoke in the rear of the device. Device was disconnected from power and removed from the room. Damaged part was replaced by field service technician and the device placed back in service after successful testing.
Patient Sequence No: 1, Text Type: N, H10
[45592342]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016493-2015-00458 |
| MDR Report Key | 4818852 |
| Report Source | 00,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-06-04 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2009-08-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN BILELLO |
| 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 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 921214386 |
| 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 | 3500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 921214386 US 921214386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |