MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ ADULT MANUAL RESUSCITATOR ¿ OXYGEN RESERVOIR BAG, ADULT MASK; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	RESUS, ADLT W/MASK, RESV BAG, 6/CS
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2023
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.
Event or Problem Description
It was reported to vyaire medical that the 2k8004 - resus, adlt w/mask, resv bag, 6/cs did not inflate while the patient was coding.The nurse pulled another bag, and it also wouldn't inflate.A second and third bag were pulled, and they also did not inflate.Finally, the fourth bag inflated.The patient's impact or harm is currently unknown.
Additional Manufacturer Narrative
Based on the investigation and since the customer sent two opened physical samples of the fg part number 2k8004, the lot number is unknown for the investigation.The physical samples were functionally inspected by quality personnel from the assembly area in accordance with pqas 2k8000 etal, performing a leak test, an air flow and solvent effectiveness test, a pull test, an inhalation test, and an exhalation test, finding the physical samples acceptable in all the tests performed, thereby not confirming the reported defect.Additionally, quality personnel from the incoming area performed a leak test in accordance with rmqas 65-4794a etal pvc bags to component adult reservoir bag part number 65-4794a, finding physical samples acceptable.In addition, the device history record of the fg part number 2k8004 with lot number 0004258319 was reviewed, and no issues were found during its manufacturing.Additionally, pfmea-08b-007 was reviewed, but since the reported defect was not confirmed, we could not associate it with an existing failure mode.Based on the above, the root cause was not established.

• Brand Name: AIRLIFE¿ ADULT MANUAL RESUSCITATOR ¿ OXYGEN RESERVOIR BAG, ADULT MASK
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18544358
• Report Number: 8030673-2024-00370
• Device Sequence Number: 18123433
• Product Code: OEV
• UDI-Device Identifier: 10190752114104
• UDI-Public: (01)10190752114104(10)0004258319
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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, RESV BAG, 6/CS
• Device Catalogue Number: 2K8004
• Device Lot Number: 0004258319
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/24/2024
• 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: Required Intervention
• Patient Sex: Unknown