MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-07-15 for PYXIS ANESTHESIA SYSTEM (PAS) PAS4000 manufactured by Carefusion.
[49750468]
Carefusion received a medwatch (sus ms5062755) on (b)(6) 2016 from (b)(6). The medwatch does not discuss anesthesia system es directly in the event description section however it is listed in the product codes in the device information section. Carefusion reviewed all records from (b)(6) and did not find a record that correlates with the information in the medwatch. Neither the medwatch or any of the legacy health system records indicate patient or user harm.
Patient Sequence No: 1, Text Type: N, H10
[49750469]
Customer reports that the pyxis es system including anesthesia system es experiences extended downtime. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016493-2016-00005 |
| MDR Report Key | 5799211 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-15 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-06-28 |
| Date Mfgr Received | 2016-06-28 |
| Date Added to Maude | 2016-07-15 |
| 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 |
| 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 | 2016-07-15 |
| Model Number | PAS4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-07-15 |