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U.S. Department of Health and Human Services

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

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AOK TOOLING LIMITED ADAPTER NEO-VERSO INF/NEO 45' SWIVEL CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
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.
 
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Brand NameADAPTER NEO-VERSO INF/NEO 45' SWIVEL
Type of DeviceCIRCUIT, 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 Key6576864
MDR Text Key75482748
Report Number2050001-2017-00058
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D079431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
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 Received05/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCSC600
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? No
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: 05/18/2017 Patient Sequence Number: 1
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