MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-19 for PYXIS ANESTHESIA SYSTEM (PAS) PAS 4000 NA manufactured by Carefusion.
[5684207]
Customer reported seeing smoke from the pyxis anesthesia device. No pt or user was harmed.
Patient Sequence No: 1, Text Type: D, B5
[13178488]
Mfg's initial report date: (b)(4) 2015. Add'l data/ failure investigation. Technical investigation revealed clear evidence of fluid ingress in the back-up battery supply on the rear of the device contributing to the reported smoke from the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016493-2015-00001 |
| MDR Report Key | 4649724 |
| Report Source | 07 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-02-21 |
| Date of Event | 2015-02-21 |
| Date Mfgr Received | 2015-02-21 |
| Device Manufacturer Date | 2014-10-14 |
| Date Added to Maude | 2015-05-12 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHIP IVERSON, MGR, CUST ADVOCA |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586175207 |
| 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 | 2015-03-19 |
| Model Number | PAS 4000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| 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 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-19 |