MAUDE Adverse Event Report: AOK TOOLING LIMITED ADAPTER NEO-VERSO INF/NEO 45' SWIVEL; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number CSC600

Device Problem Break (1069)

Patient Problems Bradycardia (1751); Hypoxia (1918)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) - the device has not been returned for investigation.If the device is received, a follow-up will be submitted.

Event Description

Customer stated verbally via telephone "in an emergency, the childs heart rate was dropping they weren't receiving enough oxygen.They went to disconnect and the part broke off at the swivel." additional details received via email: ¿infant desaturated and became bradycardic, requiring ambu breaths.When i attempted to disconnect neolink device from ett to apply ambu bag, the top of the device detached from the base.The base remained lodged on the blue hub of the ett, 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 ett and provide ambu breaths.¿ the patient is stable and does not seem to have complications related to the event.The neolink has been on this patients¿ ett for a long time, therefore i do not have the original package or lot number.I am concerned about 2 things: the fact that this device is difficult to remove from the endotracheal tube in an emergency when the patient requires manual ventilation.The fact that one of the devices separated when a nurse needed to remove it from the patient in an emergency.

• Brand Name: ADAPTER NEO-VERSO INF/NEO 45' SWIVEL
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): AOK TOOLING LIMITED; CH
• Manufacturer (Section G): AOK TOOLING LIMITED; long-tien village,keng zi town; long gang district; shenxhen ; CH
• Manufacturer Contact: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6576864
• MDR Text Key: 75482748
• Report Number: 2050001-2017-00058
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D079431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CSC600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention