MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-19 for ACUDOSE * manufactured by Aesynt Corporation.
[21245631]
The certified registered nurse anesthetist (crna) was trying to log into anesthesia acudose. When she went to use the machine the system was frozen. Neither the keyboard nor the touchscreen would respond. We rebooted the machine with the button on the left side. It took 3-4 minutes to reboot. Once the system came back up everything was working at its normal pace. Aesynt was called. They said they will reach back to us within 24 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4143254 |
| MDR Report Key | 4143254 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-19 |
| Date of Event | 2014-09-17 |
| Report Date | 2014-09-19 |
| Date Reported to FDA | 2014-09-19 |
| Date Reported to Mfgr | 2014-10-06 |
| Date Added to Maude | 2014-10-06 |
| 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 |
| Generic Name | ANESTHESIA CART |
| Product Code | BRY |
| Date Received | 2014-09-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT CORPORATION |
| Manufacturer Address | 500 CRANBERRY WOODS DRIVE CRANBERRY TOWNSHIP PA 16066 US 16066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-19 |