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

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/18/2022

Event Type  Death  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 302393696
• Report Number: 8030673-2022-00276
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752114258
• UDI-Public: (01)10190752114258(10)0004067132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 14 KG