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

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.

• Brand Name: AIRLIFE NEO-VERSO
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION 2200, INC.; 22745 savi ranch pkwy.; yorba linda CA 92887
• MDR Report Key: 6618453
• MDR Text Key: 76865173
• Report Number: 6618453
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 06/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CSC600
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.; NOT KNOWN.