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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Ge healthcare as investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that during a case, the patient had to be resuscitated.At the time of resuscitation, co2 had disappeared and halothane appeared on the device display.The patient recovered.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the aisys anesthesia device and the gas module and did not identify any issue with either device.Ge healthcare product engineering performed an investigation of this event.Per information in the complaint, the hospital staff confirmed the aisys anesthesia device never lost ventilation.The patient had to be resuscitated.The hospital staff declined to provide any additional information.As such, the date and time of the case could not be determined.The system logs were reviewed.There were occurrences of a loss of co2, however, it was not possible to determine which occurrences related to the event because the hospital did not disclose the date and time.The logs do not indicate any device malfunction that would align with missing co2 displayed values.Review of complaint data indicates no malfunction of the aisys anesthesia device or the gas module.The root cause of the of the loss of co2 and the patient resuscitation is undetermined.Based on the investigation, these devices did not cause or contribute to the adverse event.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 10683291
• MDR Text Key: 211490681
• Report Number: 2112667-2020-02844
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1