• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE NEO-VERSO CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION 2200, INC. AIRLIFE NEO-VERSO CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number CSC600
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)
Event Date 05/02/2017
Event Type  malfunction  
Event Description
Infant desaturated and became bradycardic, requiring ambu breaths. When i attempted to disconnect the neolink device from et tube to apply ambu bag, the top of the device detached from the base. The base remained lodged on the blue hub of the et tube, making it impossible to attach and ambu bag to provide breaths. It was several seconds before i was able to remove the base of the neolink from the et tube and provide ambu breaths. Manufacturer response for access adapter, airlife neo-veson airway access adapter (per site reporter). Not known.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAIRLIFE NEO-VERSO
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
CAREFUSION 2200, INC.
22745 savi ranch pkwy.
yorba linda CA 92887
MDR Report Key6618453
MDR Text Key76865173
Report Number6618453
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/08/2017,05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCSC600
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/08/2017
Event Location Hospital
Date Report to Manufacturer05/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/07/2017 Patient Sequence Number: 1
Treatment
NOT KNOWN.; NOT KNOWN.
-
-