MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 12/25/2015

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment.The unit was calibrated as well as replacement of the following parts: display unit, anesthesia control board, display connector board, and harness.The unit was returned to service.

Event Description

The hospital alleges that the unit shut down.There was no report of patient involvement.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: brad wheeler ; 3000 n. grandview blvd., w450; waukesha, WI 53188
• MDR Report Key: 5367999
• MDR Text Key: 36000528
• Report Number: 2112667-2016-00066
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1