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

Device Problem Output Problem (3005)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

A gehc service representative performed a checkout of the equipment.The co2 bypass valve and o-rings were replaced.Patient information could not be obtained after multiple attempts.Attempts were made as follows: 7/09/18 phone call, 07/10/18 phone call, 07/11/18 phone call.

Event Description

The hospital reported that, during a case, higher than expected level of carbon dioxide was noted.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: 7677996
• MDR Text Key: 113744979
• Report Number: 2112667-2018-01362
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1