MAUDE Adverse Event Report: GENERAL ELECTRIC GE CARESCAPE R860 VENTILATOR

Model Number G1500197

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

During repositioning of patient ventilator circuit popped off of et tube.Ventilator circuit reconnected to et tube, ventilator alarming "tube block," message would not go away and unable to restart.Child required bagging switched out with another ventilator.Stat cxr showed that the et tube had advanced into the right mainstem bronchus.Et tube pulled back and repeat cxr confirmed position.

• Brand Name: GE CARESCAPE R860 VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): GENERAL ELECTRIC ; 41 farnsworth st.
• MDR Report Key: 11357699
• MDR Text Key: 233741848
• Report Number: 11357699
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2021

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
• Device Model Number: G1500197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2021
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 12