MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	AIRLIFE¿ INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the neonatal resuscitator bag used to ventilate patient in the emergency department during intubation had a manufacturer's defect where the high pressure o2 tubing disconnected inside the large bore tubing.This event occurred while connected to a premature patient and this lead to desaturation and bradycardia, compression initiated for one minute and the patient was transferred to another pediatric resuscitator bag and the patient's heart rate and spo2 back to normal.
Additional Manufacturer Narrative
Device evaluation: d4, g4, g7, h2, h3, h6 and h10.Result of investigation: vyaire medical was unable to verify the customer's reported issue.The device history record review showed no deviations in manufacturers specifications, and no product was returned for evaluation; therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.

• Brand Name: AIRLIFE INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10058079
• Report Number: 8030673-2020-00096
• Device Sequence Number: 2715193
• Product Code: OEV
• UDI-Device Identifier: 10885403103155
• UDI-Public: (01)10885403103155(10)0004020711
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING
• Device Catalogue Number: 2K8038
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Weight: 4