MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-20 for PYXIS ANESTHESIA SYSTEM (PAS) PAS ES manufactured by Carefusion.
[90746359]
(b)(4). Additional data / failure investigation: field service technician on site found unit to have a loose bracket inside the controller board cover. The loose bracket came into contact with the controller board and caused the board to short out. The loose bracket and controller board were replaced by field service technician.
Patient Sequence No: 1, Text Type: N, H10
[90746360]
Customer reports seeing visible puff of smoke come from the rear of the drawer when they pulled it open. No harm caused to patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2017-00002 |
| MDR Report Key | 6966149 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| 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 | 2017-10-20 |
| 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 | 2017-10-20 |