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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC GE CARESCAPE R860 VENTILATOR

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GENERAL ELECTRIC GE CARESCAPE R860 VENTILATOR Back to Search Results
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.
 
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Brand Name
GE CARESCAPE R860 VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
GENERAL ELECTRIC
41 farnsworth st.
MDR Report Key11357699
MDR Text Key233741848
Report Number11357699
Device Sequence Number1
Product Code CBK
Reporter Country CodeUS
Number of Events Reported1
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 NumberG1500197
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/11/2021
Device Age3 YR
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/22/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age3 YR
Patient Weight12
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