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

Model Number	AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of this time, no sample has been returned.There are three(3) lot numbers available for this sample: 0004118094, 0004111662 and 0004095580.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the airlife adult manual resuscitator experienced a defect problem.In post anesthesia care unit, patient experienced difficulty breathing.So they bagged the patient to continue breathing.But due to hose at base of ambu bag was kinked or pinched, it did not allow adequate oxygen to flow into the ambu bag.When the issue occurred, the patient's spo2 were not coming up from low 80%, once identified staff were able to get line open enough to bring patient's spo2 up to 99%.

• Brand Name: AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9777287
• Report Number: 8030673-2020-00079
• Device Sequence Number: 1431893
• Product Code: OEV
• UDI-Device Identifier: 10885403170249
• UDI-Public: (01)10885403170249
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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 ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
• Device Catalogue Number: 2K8004
• Device Lot Number: 0004118094, 0004111662
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• 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