ACUDOSE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-19 for ACUDOSE manufactured by Aesynt Incorporated.

Event Text Entries

[65263763]
Patient Sequence No: 1, Text Type: N, H10


[65263764] While performing required manual count of acudose dispensing cabinet a "cabinet error" occurred as the nurses were counting drawer 12, pocket 3. The error was able to be cleared, but this halted the progress of the count as the nurses were not able to resume where they had left off.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6263526
MDR Report Key6263526
Date Received2017-01-19
Date of Report2017-01-18
Date of Event2017-01-16
Report Date2017-01-18
Date Reported to FDA2017-01-18
Date Reported to Mfgr2017-01-18
Date Added to Maude2017-01-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACUDOSE
Generic NameMEDICATION DISPENSING SYSTEM
Product CodeBRY
Date Received2017-01-19
ID NumberSTATION ID: SURG
OperatorNURSE
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESYNT INCORPORATED
Manufacturer Address500 CRANBERRY WOODS DR. CRANBERRY TOWNSHIP PA 16066 US 16066


Patients

Patient NumberTreatmentOutcomeDate
10 2017-01-19

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