MAUDE Adverse Event Report: VYAIRE MEDICAL VYAIRE MEDICAL INC; RESUSCITATION, ADLT W/MASK, 40" TBG,

Model Number	275224
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 10 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the fda medwatch report received from upmc where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife.Product is defective or caused serious injury.
Event or Problem Description
Received a medwatch report from fda stating that there was a product malfunction with a device that was included in a product recall.
Additional Manufacturer Narrative
All information reasonably known as of 10 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the fda medwatch report received from upmc where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife.Product is defective or caused serious injury.There will not be an investigation follow up on the complaint since the customer will not be pursuing any action on this matter.
Event or Problem Description
Recieved a medwatch report from fda stating that there was a product malfunction with a device that was included in a product recall.

• Brand Name: VYAIRE MEDICAL INC
• Common Device Name: RESUSCITATION, ADLT W/MASK, 40" TBG,
• Manufacturer (Section D): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19294142
• Report Number: 8030673-2024-01006
• Device Sequence Number: 8739819
• Product Code: OEV
• UDI-Device Identifier: 10190752114159
• UDI-Public: 10190752114159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 275224
• Device Catalogue Number: 268005
• Device Lot Number: 0004173743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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: Other
• Patient Sex: Unknown