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

Device Problem Improper Flow or Infusion (2954)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/28/2022

Event Type  Injury  

Event Description

The hospital reported a patient connected to an avance cs2 had a sudden drop in blood pressure at 5:58.Resuscitation measures were given.At 6:00, it was determined that the bellows of the avance cs2 were not being supplied with air.The avance cs2 was restarted, normal ventilation resumed, and patient recovered.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information is available.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The root cause is undetermined, because there is no evidence of device malfunction, and it is unknown whether the device contributed to the patients drop in blood pressure.The device logs show that the system checkout was bypassed prior to the case, and after the reported incident, the case continued for 9 hours.The logs also show that the bellows collapsed at 6:00am, 2 minutes after the reported time of the occurrence.Further, the logs reveal no alarms/errors 10 minutes prior to the blood pressure drop.Due to the machine functioning normally for the rest of the case without any maintenance noted in the complaint or seen in the device logs, the most likely scenario is that there was a leak or disconnect in the patient breathing circuit which caused the bellows to collapse.The patients blood pressure likely dropped due to their poor condition during surgery, the sedation drugs given, and/or a leak in the breathing system.

• Brand Name: AVANCE 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: 14592807
• MDR Text Key: 293268449
• Report Number: 2112667-2022-01388
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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