MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-09 for ACUDOSE * manufactured by Aesynt Incorporated.
[6050856]
For the past 2 monday mornings, the acudose has malfunctioned during the weekly count of the controlled medications. This has resulted in having to start over after the machine is re-booted, adding even more time to this time-consuming process. Last week it resulted in the off going charge nurse having to stay well past the end of her shift; this week it resulted in 2 patients experiencing a delay in receiving medications their nurses needed to dispense from the acudose. Two members of the pharmacy team had to leave their other duties to come trouble-shoot the acudose machine as it would not restart once the nurses shut it down as instructed. A cabinet error also occurred later in the morning again, but the machine was able to self-clear it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4931119 |
| MDR Report Key | 4931119 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-07-06 |
| Report Date | 2015-07-09 |
| Date Reported to FDA | 2015-07-09 |
| Date Reported to Mfgr | 2015-07-22 |
| Date Added to Maude | 2015-07-22 |
| 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 |
| Generic Name | CABINET, TABLE AND TRAY, ANESTHESIA |
| Product Code | BRY |
| Date Received | 2015-07-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT INCORPORATED |
| Manufacturer Address | 500 CRANBERRY WOODS DR., SUITE CRANBERRY TOWNSHIP PA 16066 US 16066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-09 |