MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-10 for ACUDOSE-RX HOSPITAL ID AGOR6 * manufactured by Aesynt, Incorporated.
[5222904]
The nurse was pulling rocuronium bromide for a patient he was taking care of and the unrecoverable error message popped up, then the machine rebooted itself. It took approximately 4 minutes to go through the cycle and pull it back up online. The machine worked fine after he logged back in. There was no harm to the patient or any adverse effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4344924 |
| MDR Report Key | 4344924 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-12-10 |
| Date of Event | 2014-12-03 |
| Report Date | 2014-12-10 |
| Date Reported to FDA | 2014-12-10 |
| Date Reported to Mfgr | 2014-12-19 |
| Date Added to Maude | 2014-12-19 |
| 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 | 2014-12-10 |
| Model Number | HOSPITAL ID AGOR6 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| 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 | 2014-12-10 |