MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-28 for PYXIS ANESTHESIA SYSTEM (PAS) 3500 manufactured by Carefusion.
[26940497]
Field service technician indicated the ups on the device popped and smoked when it was connected to power during the initial investigation of the service call. The device was disconnected from power and replaced. The device placed back in service after successful testing. Fluid was present inside the ups.
Patient Sequence No: 1, Text Type: N, H10
[26940498]
Customer reported a non-functioning pas device caused by a fluid ingression of iv fluids. There was no patient present and no harm occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2015-00002 |
| MDR Report Key | 5109169 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-28 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-09-03 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2010-06-14 |
| Date Added to Maude | 2015-09-28 |
| 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 CHIP 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 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 | 2015-09-28 |
| Model Number | 3500 |
| Catalog Number | 3500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-28 |