ACUDOSE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-27 for ACUDOSE * manufactured by Aesynt Incorporated.

Event Text Entries

[4984275] The acudose medication dispenser machine froze 3 times when trying to pull medications for patients.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4208792
• MDR Report Key: 4208792
• Date Received: 2014-10-27
• Date of Report: 2014-10-27
• Date of Event: 2014-10-20
• Report Date: 2014-10-27
• Date Reported to FDA: 2014-10-27
• Date Reported to Mfgr: 2014-10-29
• Date Added to Maude: 2014-10-29
• 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

Device Details

• Brand Name: ACUDOSE
• Generic Name: CABINET, TABLE AND TRAY, ANESTHESIA
• Product Code: BRY
• Date Received: 2014-10-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NOT APPLICABLE
• Device Availability: Y
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-10-27