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

Device Problem Inaccurate Delivery (2339)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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 low tidal volume.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that the device continued to ventilate.The reported event was not a reportable malfunction as there was no loss of ventilation.Unit continues to ventilate and alarms remain functional.Clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.H3 other text : additional information was received that the device continued to ventilate.The reported event was not a reportable malfunction as there was no loss of ventilation.Unit continues to ventilate and alarms remain functional.Clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.

• 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: 12217683
• MDR Text Key: 265394618
• Report Number: 2112667-2021-01763
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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: 06/24/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1