MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-17 for ACUDOSE-RX * manufactured by Aesynt Incorporated.
[5552084]
The nurse anesthetist (crna) was prepping for her first case. She was pulling drugs from the cart and the cart was taking 3-4 minutes between pocket to pocket dispenses. She completed her pulls and logged out. The anesthesia supervisor went in and did a hard-reboot and the cart seemed to speed up. Aesynt was called to report the event. They are investigating and going to look at similarities with last week's similar case event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4557131 |
| MDR Report Key | 4557131 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-02-17 |
| Date of Event | 2015-02-16 |
| Report Date | 2015-02-17 |
| Date Reported to FDA | 2015-02-17 |
| Date Reported to Mfgr | 2015-03-02 |
| Date Added to Maude | 2015-03-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUDOSE-RX |
| Generic Name | CABINET, TABLE AND TRAY, ANESTHESIA |
| Product Code | BRY |
| Date Received | 2015-02-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT INCORPORATED |
| Manufacturer Address | 500 CRANBERRY WOODS DR. SUITE 400 CRANBERRY TOWNSHIP PA 16066 US 16066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-17 |