MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-02 for PYXIS ANESTHESIA SYSTEM (PAS) PAS3500 manufactured by Carefusion.
[50963562]
Field service technician went on site and observed a frayed power cable on the pyxis anesthesia system at the junction of the power cord and the uninterruptible power supply (ups). The fray was caused by frequent moving of the device and pulling of the power cord without unplugging the device from the wall. Affected components were replaced.
Patient Sequence No: 1, Text Type: N, H10
[50963563]
Customer reported sparks coming from the power cord on the pyxis anesthesia 3500 system. No harm to patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2016-00006 |
| MDR Report Key | 5840584 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-02 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-07-11 |
| Date Mfgr Received | 2016-07-11 |
| Device Manufacturer Date | 2008-11-04 |
| Date Added to Maude | 2016-08-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| 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 | 2016-08-02 |
| 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 | 2016-08-02 |