MAUDE Adverse Event Report: GE HEALTHCARE AISYS; ANESTHESIA GAS MACHINE

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

A gehc service representative performed a checkout of the equipment and a review of the logs.The electronic vaporizer was replaced.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.

Event Description

The hospital reported that, during a case, higher than expected anesthetic agent output was noted.The anesthesia machine was reportedly replaced.There was no reported patient injury.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): GE HEALTHCARE; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI 53188 ; 8479711808
• MDR Report Key: 7698128
• MDR Text Key: 114323163
• Report Number: 2112667-2018-01408
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• 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: 07/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1