MAUDE Adverse Event Report: VYAIRE MEDICAL INC. 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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
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
The customer reported an issue on airlife¿ adult manual resuscitator, 40'' (1.0m) oxygen reservoir tubing, adult.Patient coded post procedure.The nurse started to bag the patient and the manual resuscitator failed to re-inflate after ventilation.Anesthesia arrived and noted the defect and they were able to establish the airway.The patient continued to be ventilated and eventually established spontaneous respirations.She was admitted over night for observation and was discharged home the following day.
Additional Manufacturer Narrative
Vyaire medical conducted a failure investigation.The device history record (dhr) review did not show any deviations to manufacturer specifications.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
The device history record of the p/n 2k8005 with lot number 0000322436 was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lot was manufactured on 27may11 per our internal procedures and no issues were found.According to investigation, we determine manufacturing personnel are related with defect reported, since they must assemble these components inside of the component p/n 65-4213e with a manual press.In the samples received these components are disassembled.It possible manufacturing personnel did not do assembly properly and it provoked defect reported on this complaint.Personnel were retrained on spm 2k8000 etal.Some pictures of a correct assembly and an incorrect assembly were added as a reference on spm 2k8000 etal.This change was completed on (b)(6) 2020.

• 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 INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11113405
• Report Number: 8030673-2020-00143
• Device Sequence Number: 19813883
• Product Code: OEV
• UDI-Device Identifier: 10190752114159
• UDI-Public: (01)10190752114159(10)0000322436
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2020

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: 2K8005
• Device Lot Number: 0000322436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 03/16/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/29/2021; 04/14/2021
• 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
• Patient Age: 69 YR