MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-12 for PYXIS ANESTHESIA SYSTEM (PAS) PAS3500 manufactured by Carefusion.
[64619904]
(b)(4). Additional data / failure investigation: field service technician on site found unit to have a bad internal power supply. Internal power supply and power cord were replaced by field service technician.
Patient Sequence No: 1, Text Type: N, H10
[64620105]
Customer reports seeing visible smoke and sparking from the pyxis anesthesia 3500 system power cord during use. No harm caused to patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2017-00001 |
| MDR Report Key | 6245499 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2016-12-16 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2017-01-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DUSTIN MCDANIEL |
| Manufacturer Street | 10020 PACIFIC MESA BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586171009 |
| 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 | 2017-01-12 |
| Model Number | PAS3500 |
| 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 | 2017-01-12 |