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

Model Number	2K8004
Medical Device Problem Codes	Defective Device (2588); No Pressure (2994)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical has received the defective component and results are pending completion of investigation.
Event or Problem Description
The customer reported while using the airlife adult manual resuscitator, an inability to ventilate.On (b)(6) 2020, the reported the patient (b)(6) year old female brought into er with agonal breathing.The customer reported the patient was not intubated initially.She coded, they bagged her[?] 1st breath was good and then lost pressure again, so they pulled the backup bag.2nd bag did not work[?] therapist left room to retrieve a 3rd bag which worked.While therapist was out of the room, the er doctor intubated the patient.After exchanging the bags (manual resuscitator), the customer reported alternative ventilation was provided to the patient.
Additional Manufacturer Narrative
Results of investigation: the vyaire failure analysis laboratory received the suspect component for investigation.One sample was provided for the investigation.Sample was not inspected functionally because it was not decontaminated, only was inspected visually and found that the components snap ring and lim duck bill are disassembled from exhalation port.Therefore, defect reported was confirmed.This issue will be internally investigated within vyaire.

• 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
• MDR Report Key: 9946472
• Report Number: 8030673-2020-00093
• Device Sequence Number: 14013359
• Product Code: OEV
• UDI-Device Identifier: 10885403170249
• UDI-Public: (01)10885403170249(11)Y10K7112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 2K8004
• Device Catalogue Number: 2K8004
• Device Lot Number: Y10K7112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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
• Patient Age: 87 YR