ACUDOSE-RX *

MAUDE Adverse Event Report

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 * manufactured by Aesynt Incorporated.

Event Text Entries

[5138888] The nurse was taking care of the patient during a surgical procedure. While she was trying to manage her medications on her anesthesia rx cart, the system froze for about 5 minutes. This was mid procedure. The nurse called her supervisor and right before he walked in the room the cart responded. There was no harm to the patient. The supervisor called the case into aesynt. The cart seems to be responding in its normal speed now.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4344869
• MDR Report Key: 4344869
• Date Received: 2014-12-10
• Date of Report: 2014-12-10
• Date of Event: 2014-12-09
• 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: 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-RX
• Generic Name: CABINET, TABLE AND TRAY, ANESTHESIA
• Product Code: BRY
• Date Received: 2014-12-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• 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		2014-12-10