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

Device Problems No Device Output (1435); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2015

Event Type  Injury  

Event Description

The hospital reported that, during a case, mechanical ventilation stopped.The unit reportedly alarmed for a leak.The clinician reportedly switched to manual mode, tried to manually ventilate the pt, but was not successful.Cpr was performed and the pt reportedly recovered.

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A f/u report will be issued when the investigation has been completed.

Manufacturer Narrative

Ge healthcare service representative performed a checkout of the equipment.The equipment was checked and found to function within manufacturer's specifications.The logs were downloaded and forwarded to the manufacturing site for analysis.The logs were reviewed and found to contain multiple entries consistent with a patient ventilation leak.According to the hospital, the leak was resolved following reintubation of the patient.The reported details of the event, a review of the logs, and the proper ventilation being achieved after the successful reintubation of the patient are all consistent with a patient breathing system leak at the intubation interface with the patient.A preoperative checkout of the equipment, such as contained in the aisys cs2 user reference manual, is designed to pick up such a leak condition.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA ; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4959514
• MDR Text Key: 22152180
• Report Number: 2112667-2015-00096
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 72