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

Model Number	RESUS, ADLT W/MASK, LRG TBG, 6/CS
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/10/2023
Type of Reportable Event	Death
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.Device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the resus, adlt w/mask, lrg tbg, 6/cs has failed in providing air to the patient.Instead of providing air the ambubag was getting air from the patient.The patient was died due to this failure.
Additional Manufacturer Narrative
Result of investigation: based on the investigation and physical sample received, the reported defect was confirmed since the physical sample was visually inspected by quality personnel from assembly area according to pqas 2k8000 etal and it was found that component lim duck bill part number 68-10a was detached, as well as detached component vinyl tubing part number 58-1831.Based on the above, we determined that manufacturing personnel may be related with the reported defect since they did not follow properly the instructions indicated on spm 2k8000 etal; that establishes they must assemble component lim duck bill part number 68-10a correctly on every fg part number 2k8017, as well as the correct assemble of component vinyl tube part number 58-1831.In addition, the device history record should be reviewed as part of the investigation, however since the fg part number 2k8017 with lot number y07e1865 was manufactured in 2007, the device history record is not available.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE¿ MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
• 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: 17506908
• Report Number: 8030673-2023-00345
• Device Sequence Number: 15077111
• Product Code: OEV
• UDI-Device Identifier: 10190752114296
• UDI-Public: (01)10190752114296(10)407E1865
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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, LRG TBG, 6/CS
• Device Catalogue Number: 2K8017
• Device Lot Number: 407E1865
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown