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

Model Number 1011-9050-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/10/2023

Event Type  Injury  

Event Description

The hospital reported a patient was connected to an aisys cs2 when it was alleged that the patients oxygen saturation dropped.Reportedly, the patient was switched to manual ventilation and the saturation level returned to normal.The patient was the switched to mechanical ventilation and the oxygen saturation level dropped.The facility replaced the breathing circuit, reintubated the patient and case resumed without incident.There was no patient sequelae.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcareâs (gehc) fe performed a checkout of the aisys cs2 but could not confirm the reported issue.Gehcs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: no patient information provided to date.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

Manufacturer Narrative

Additional information was received that there was no malfunction of the anesthesia machine.In addition, the desaturation level and duration did not and would not lead to patient injury.The issue did not cause or contribute to a death or serious injury and it is unlikely to result in a death or serious injury, illness, deterioration of state of health or harm should it recur.H3 other text : additional information was received that there was no malfunction of the anesthesia machine.In addition, the desaturation level and duration did not and would not lead to patient injury.The issue did not cause or contribute to a death or serious injury and it is unlikely to result in a death or serious injury, illness, deterioration of state of health or harm should it recur.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 18322519
• MDR Text Key: 330413025
• Report Number: 2112667-2023-06661
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention