MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; SM ADULT AIRFLOW RESUS BAG

Model Number	AF5040MB
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Face masks inside the kit are flat (underinflated).
Additional Manufacturer Narrative
The mask deflating and not properly sealing to patient would cause a disruption in resuscitation efforts and put them at risk.
Event or Problem Description
Face masks inside the kit are flat(underinflated).
Additional Manufacturer Narrative
The mask deflating and not properly sealing to patient would cause a disruption in resuscitation efforts and put them at risk.Summary: complaint confirmed via returned devices.The masks are able to be inflated and used properly.The customer was notified of potential causes for deflated masks.Ra: instructions for mask use in combination with rma-20020 are sufficient risk analysis for the reported product complaint.

• Brand Name: SUNMED LLC
• Common Device Name: SM ADULT AIRFLOW RESUS BAG
• 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: 17279423
• Report Number: 1314417-2023-00018
• Device Sequence Number: 14723980
• Product Code: BTM
• UDI-Device Identifier: 10889483079126
• UDI-Public: 10889483079126
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/07/2023

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: AF5040MB
• Device Catalogue Number: AF5040MB
• Device Lot Number: 21300279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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