MAUDE Adverse Event Report: WESTMED, INC NEO-VENT INFANT RESUSCITATION CIRCUIT; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number 0415

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Neo-vent infant resuscitation circuit did not connect to infant resuscitator.Clinician went to use the resuscitation circuit and it would not connect to the panda infant resuscitator.The circuit had previously been able to connect to the resuscitator.Because of this the patient was put at risk and an additional method of resuscitation had to be used.

• Brand Name: NEO-VENT INFANT RESUSCITATION CIRCUIT
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): WESTMED, INC
• MDR Report Key: 8339477
• MDR Text Key: 136859317
• Report Number: MW5084057
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0415
• Device Catalogue Number: 0415
• Device Lot Number: 08062018N30
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening