ACUDOSE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-15 for ACUDOSE * manufactured by Aesynt Incorporated.

Event Text Entries

[4769905] The physician was relieving another provider in operating room (or). The other provider logged out of acudose cart. The patient was waking up, so the physician did not log in thinking he wouldn't need anything. The patient started to wake and bit down on his tube. The physician went to log in to get an airway and when he went to select the unlock button nothing happened and the screen froze. He was not able to access the cart so they sent out for an airway cart. They were able to complete the case and the patient went to post-anesthesia care unit (pacu). The physician said the patient was fine. The machine worked fine earlier in the morning.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	4143431
MDR Report Key	4143431
Date Received	2014-09-15
Date of Report	2014-09-15
Date of Event	2014-09-10
Report Date	2014-09-15
Date Reported to FDA	2014-09-15
Date Reported to Mfgr	2014-10-06
Date Added to Maude	2014-10-06
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	0
Product Problem Flag	3
Reprocessed and Reused Flag	0
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	CABINET, TABLE AND TRAY, ANESTHESIA
Product Code	BRY
Date Received	2014-09-15
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	Y
Device Sequence No	0
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		2014-09-15