MAUDE Adverse Event Report: GE HEALTHCARE GE DATEX-OHMEDA AISYS ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  Injury  

Event Description

Ge datex-ohmeda aisis anesthesia machine underwent checkout procedure without any issues.Immediately prior to induction of anesthesia, it was recognized that all of the buttons that control oxygen flow, fio2, ventilator settings, and inhaled anesthetic concentration were not functional.Anesthesia machine was changed out, and patient was unharmed.However, if this malfunction had not been recognized (and it was not picked up by the anesthesia machine's automated checkout), then general anesthesia could have been induced with no way to provide an inhaled anesthetic, adjust ventilator settings, gas flows, or fio2.

• Brand Name: GE DATEX-OHMEDA AISYS ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE; waukesha WI 53188
• MDR Report Key: 7518241
• MDR Text Key: 108551551
• Report Number: MW5077249
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention