MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-25 for ACUDOSE-RX * manufactured by Aesynt Incorporated.
[4744281]
The physician was pulling drugs for a labor and delivery case and the screen of the unit froze. He then pushed the anesthesia rx icon and the windows trouble shooting box appeared but would not clear in an acceptable amount of time for the physician. There seems to be an issue with quickly moving through the process without the machine freezing up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4083793 |
| MDR Report Key | 4083793 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-08-25 |
| Date of Event | 2014-08-23 |
| Report Date | 2014-08-25 |
| Date Reported to FDA | 2014-08-25 |
| Date Reported to Mfgr | 2014-09-12 |
| Date Added to Maude | 2014-09-12 |
| 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 | 0 |
| 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 | 2014-08-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT INCORPORATED |
| Manufacturer Address | 500 CRANBERRY WOODS DRIVE CRANBERRY TOWNSHIP PA 16066 US 16066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-25 |