MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-24 for ACUDOSE RX * manufactured by Aesynt Incorporated.
[4774719]
The anesthesia supervisor went to re-stock medications into the cart. The machine was frozen and neither the touch screen nor the keyboard would respond. The operator was unable to log in. The operator tried re-booting the machine with the black reset button on the left. The machine only re-booted after a full reset with the key the 2 reset switches on the right side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3994212 |
| MDR Report Key | 3994212 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-24 |
| Report Date | 2014-07-24 |
| Date Reported to FDA | 2014-07-24 |
| Date Reported to Mfgr | 2014-08-08 |
| Date Added to Maude | 2014-08-08 |
| 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 | 2014-07-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | * |
| Device Age | * |
| 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 | 2014-07-24 |