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 2014-07-24 for ACUDOSE-RX * manufactured by Aesynt Incorporated.

Event Text Entries

[15813837] The physician was pulling medications for his patient. He pulled fentanyl, then while pulling midazolam the machine popped the "unrecoverable error" message then rebooted. Patient was on the table and it was prior to anesthesia being administered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3994220
MDR Report Key3994220
Date Received2014-07-24
Date of Report2014-07-24
Date of Event2014-07-23
Report Date2014-07-24
Date Reported to FDA2014-07-24
Date Reported to Mfgr2014-08-08
Date Added to Maude2014-08-08
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-RX
Generic NameCABINET, TABLE AND TRAY, ANESTHESIA
Product CodeBRY
Date Received2014-07-24
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
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 2014-07-24

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