MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number AIRLIFE¿ PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING

Device Problem Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported that the product sample is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that there was no oxygen flow within airlife pediatric manual resuscitator, variable volume oxygen reservoir tubing.The device was attached to the oxygen source but the anesthesiologist cannot hear the oxygen flow.They removed the device from the corrugated tubing, and the customer reported that they were able to hear and feel the oxygen from the end of the tubing.This event occurred while connected to a patient and this lead to poor perfusion.The customer confirmed that no medical intervention was performed to the patient.

Manufacturer Narrative

Device evaluation: d4, g4, h2, h3, h6 and h10.Result of investigation: the vyaire failure analysis laboratory performed analysis on the sample received.Two opened samples of the product p/n 2k8018 without lot number were received for evaluation.A flow test was performed and no issues were found.Therefore, the defect reported by the customer was not confirmed and no root cause was determined.

• Brand Name: AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9513447
• MDR Text Key: 179444075
• Report Number: 8030673-2019-00061
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING
• Device Catalogue Number: 2K8018
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other