MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ MANUAL RESUSCITATOR INFANT MANUAL RESUSCITATOR 40 INCH (1.0 M) OXYGEN R; PULMONARY RESUSCITATOR, MANUAL, SINGLE-USE

Model Number	RESUS, INF W/MASK, 40" TBG,P/O, 6/CS
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/18/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported to vyaire medical that the pediatric patient arrived pulseless and not breathing.The patient was manually ventilated and it was noticed that it was hard to ventilate but also felt an air leak when compressing the 2k8010 - resus, inf w/mask, 40" tbg,p/o, 6/cs.They found the oxygen attachment stem near the elbow for the patient interface was cracked off.The customer held her thumb over the leak and requested another resuscitation bag.The replacement bag provided to her had the same problem.The third bag provided was intact and functioning correctly.Following this event, she found another resuscitation bag within the ed (emergency department) with a cracked oxygen stem.
Additional Manufacturer Narrative
"at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, it was confirmed that the patient was deceased.There was no relevant medical history noted in patient's chart.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 INFANT MANUAL RESUSCITATOR 40 INCH (1.0 M) OXYGEN R
• Common Device Name: PULMONARY RESUSCITATOR, MANUAL, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la producci?n; no. 85, parque undustrial; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 15671238
• Report Number: 8030673-2022-00276
• Device Sequence Number: 6372634
• Product Code: OFP
• UDI-Device Identifier: 10190752114258
• UDI-Public: (01)10190752114258(10)0004067132
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 09/28/2022

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, INF W/MASK, 40" TBG,P/O, 6/CS
• Device Catalogue Number: 2K8010
• Device Lot Number: 0004067132
• 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: 09/28/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 14 KG