MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-18 for PYXIS ANESTHESIA SYSTEM (PAS) 4000 manufactured by Carefusion.
[31571778]
(b)(4). Additional data / failure investigation. Field service technician on site reported the customer spilled iv solution on the device which ingressed into the ups and caused a short out.
Patient Sequence No: 1, Text Type: N, H10
[31571779]
Customer reports seeing a small amount of smoke and hearing a popping sound from the ups on the pyxis anesthesia system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2015-00003 |
| MDR Report Key | 5234374 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-18 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-11-04 |
| Date Mfgr Received | 2015-11-04 |
| Device Manufacturer Date | 2014-03-06 |
| Date Added to Maude | 2015-11-18 |
| 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 | CARL IVERSON |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586175207 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| 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 | 2015-11-18 |
| 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 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-18 |