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

Model Number	AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has 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
The customer reported that the airlife¿ adult manual resuscitator, 40'' (1.0m) oxygen reservoir tubing, adult mask experienced patient ambu bag was not seeming to fill with air or there was no resisting of the bag.Patient o2 saturation dropped.As an intervention, different ambu bag was used.
Additional Manufacturer Narrative
Result of investigation: the physical sample was received.Found broken defect on the component.According to the investigation, root cause was undetermined but the damage in the unit provided could be attributed to misuse by the customer.

• Brand Name: AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M)
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11780670
• Report Number: 8030673-2021-00162
• Device Sequence Number: 3998161
• Product Code: OEV
• UDI-Device Identifier: 10885403006678
• UDI-Public: (01)10885403006678
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
• Device Catalogue Number: 2K8005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention