ACUDOSE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for ACUDOSE * manufactured by Aesynt Incorporated.

Event Text Entries

[6049826] Acudose top drawer keeps making a "cabinet error" message. The message was cleared and the drawer still did not open at all. Nurse called the company. A problem with the drawer is additional pockets are "green" which means they can be opened and thus the medication is available in the pockets. This has been an on-going problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4931073
MDR Report Key4931073
Date Received2015-07-21
Date of Report2015-07-21
Date of Event2015-07-18
Report Date2015-07-21
Date Reported to FDA2015-07-21
Date Reported to Mfgr2015-07-22
Date Added to Maude2015-07-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACUDOSE
Generic NameCABINET, TABLE AND TRAY, ANESTHESIA
Product CodeBRY
Date Received2015-07-21
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerAESYNT INCORPORATED
Manufacturer Address500 CRANBERRY WOODS DR. SUITE 400 CRANBERRY TOWNSHIP PA 16066 US 16066


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-21

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