MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; SM ADULT W/MAN,MASK AND PEEP

Model Number	AF5140MBP
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See also complaint (b)(4) reported for same issue, different size (pediatric).Replacing with product that has the new patient valve.Reportable as they would not be able to properly ventilate patient.Delay in care.
Event or Problem Description
Bags not holding pressure.
Additional Manufacturer Narrative
See also (b)(4) reported for same issue, different size (pediatric).Replacing with product that has the new patient valve.Reportable as they would not be able to properly ventilate patient.Delay in care.Summary: returned product was tested and found to be in conformance.Customer was notified of performance and a video of the testing was shared.Ra: no risk associated with conforming product.
Event or Problem Description
Bags not holding pressure.

• Brand Name: SUNMED LLC
• Common Device Name: SM ADULT W/MAN,MASK AND PEEP
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17043503
• Report Number: 1314417-2023-00011
• Device Sequence Number: 8577399
• Product Code: NHK
• UDI-Device Identifier: 10889483074725
• UDI-Public: 10889483074725
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: AF5140MBP
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 416728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (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