ACUDOSE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-27 for ACUDOSE * manufactured by Aesynt Incorporated.

Event Text Entries

[15903219] Acudose machine continues to malfunction. Narcotic pockets are still available (green light) to be opened without asking for the medication. Pharmacy personnel are aware and drawer is to be replaced. No access to drawer one for the staff to access medication, thus the nurses are required to walk to a different unit for medication increasing the time interval between the time patient calls for medication and administration is done.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4945121
• MDR Report Key: 4945121
• Date Received: 2015-07-27
• Date of Report: 2015-07-27
• Date of Event: 2015-07-26
• Report Date: 2015-07-27
• Date Reported to FDA: 2015-07-27
• Date Reported to Mfgr: 2015-07-28
• Date Added to Maude: 2015-07-28
• 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: MEDICATION DISPENSING SYSTEM
• Product Code: NXB
• Date Received: 2015-07-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: *
• 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		2015-07-27