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

Model Number	RESUS, ADLT W/MASK, 40 TBG, 6/CS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Oxygen Saturation (2477)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - 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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the patient experienced a drop in oxygen levels, prompting the use of an bag valve mask for ventilation.However, attempts to provide air failed even after repositioning the patient for better airway access.Subsequently, the patient suffered a cardiac arrest, and a new bag was used and worked appropriately.The provider was attempting to test the bag, and heard a "pop" with the device, and then it functioned afterward.
Additional Manufacturer Narrative
Result of investigation: based on the investigation and per pictures received, vyaire medical was not able to to confirm the reported defect since in the picture we did not identify the customer's reported defect.We require more pictures showing the defect and/or the physical sample to perform a further investigation to look for the possible cause of the reported defect.In addition, the device history record of the fg part number 2k8005 was reviewed and no issues were found during its manufacturing.Therefore, the root cause was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was able to confirm the reported defect since the physical sample was visually inspected and it was found that vinyl tubing came detached from the o2 housing and the tubing's surface did not have enough solvent.Based on this, we determined that the equipment may be related with the reported defect since we found one solvent dispenser with an intermittent fail, which could have caused to not deliver enough solvent for the assembly between the vinyl tubing and the o2 housing , at the time the reported lot was being manufactured.However, the device history record of the fg part number 2k8005 with lot number 0004230698 was reviewed and the drop test for solvent effectiveness was properly performed as stated on spm 2k8000 etal.For this reason, we consider that it may have been an isolated case.Nonetheless, the proper semi-annual preventive maintenance was performed to the solvent dispensers as a preventive action.In addition, an improvement was made to the solvent dispensers as a corrective action to fix the intermittent failure.

• 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
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 16904110
• Report Number: 8030673-2023-00316
• Device Sequence Number: 17533212
• Product Code: OEV
• UDI-Device Identifier: 10190752114159
• UDI-Public: (01)10190752114159(10)0004230698
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

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: RESUS, ADLT W/MASK, 40 TBG, 6/CS
• Device Catalogue Number: 2K8005
• Device Lot Number: 0004230698
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 06/19/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/16/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female