MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-23 for PYXIS ANESTHESIA SYSTEM (PAS) PAS ES manufactured by Carefusion.
[118097282]
Field service technician on site determined that comm sled has a short on the circuit board. The short on the comm sled also affected the power supply. The technician replaced the comm sled and power supply and returned the comm sled to san diego for investigation. There were two cases opened for this incident; (b)(4) captured the initial customer contact and dispatch of field technician for repairs. Case (b)(4) was opened to document the parts return and investigation of root cause.
Patient Sequence No: 1, Text Type: N, H10
[118097283]
Customer reported visible smoke from the back of the anesthesia device. Device shut off immediately. No harm was caused to patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2018-00003 |
| MDR Report Key | 7809453 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-23 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2018-08-23 |
| 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 | MS. ALLISON SUAREZ |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586174995 |
| 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 | 2018-08-23 |
| Model Number | PAS ES |
| 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 | 2018-08-23 |