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

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The flow sensor was replaced to resolve the reported issue.No report of patient involvement.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 the diaphragm of the flow sensor was stuck open.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that the flow sensor was not stuck open.There are multiple medium and low-grade alarms making the user aware that there is an issue during the initial checkout of the device.The flow sensors are a customer replaceable item.The clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.The initial report was not a reportable malfunction.Additional information was received that the flow sensor was not stuck open.There are multiple medium and low-grade alarms making the user aware that there is an issue during the initial checkout of the device.The flow sensors are a customer replaceable item.The clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.The initial report was not a reportable malfunction.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 10258026
• MDR Text Key: 198907565
• Report Number: 2112667-2020-01915
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K123125
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1