MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-19 for ACUDOSE-RX * manufactured by Aesynt Incorporated.
[4827838]
Nurse anesthetist (crna) was pulling medications from anesthesia rx dispensing machine. The machine and dispense screen froze 3 times. Crna had to log off and log back in and was then able to dispense medications. This was at the beginning of a case before they administered any anesthetic medications/care. Aesynt was called to report this issue as well as the pharmacy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4083527 |
| MDR Report Key | 4083527 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-08-18 |
| Report Date | 2014-08-19 |
| Date Reported to FDA | 2014-08-19 |
| 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 | 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 | 2014-08-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| 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 | 2014-08-19 |