MAUDE Adverse Event Report: GE HEALTHCARE AVANCE CS2 ANESTHESIA MACHINE

Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pneumothorax (2012); Injury (2348)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Noticed after 3rd attempt of intubation that the exhalation side of a airway circuit connected to common gas port.Moved the exhalation side of airway and connected to exhalation port.The circuits for this machine are interchangeable.Pt safety hazard.Circuits and ports should not be interchangeable.Resulted in barotrauma and left tension pneumothorax.

• Brand Name: AVANCE CS2 ANESTHESIA MACHINE
• Type of Device: AVANCE CS2 ANESTHESIA MACHINE
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 4417590
• MDR Text Key: 5372185
• Report Number: MW5040202
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: 1-8151509278
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 93