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

Model Number	AF5140MBP
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Oxygen was coming through tubing but blowing out of side valve.Bag would not inflate & could not get oxygen to patient.
Additional Manufacturer Narrative
Oxygen was coming through tubing but blowing out of side valve.Bag would not inflate & could not get oxygen to patient. .
Additional Manufacturer Narrative
Oxygen was coming through tubing but blowing out of side valve.Bag would not inflate & could not get oxygen to patient.The complaint reported "oxygen was coming through tubing but blowing out of side valve.Bag would not inflate & could not get oxygen to patient." the complaint investigation was performed based on the content of the issue reported.Based on the complaint report the issue was found during use.However, no patient was harmed.There were no photo images or videos provided for evaluation; therefore, the complaint unconfirmed and no root cause was identified.We will continue to monitor trends during our periodic complaint review meetings.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the second (2) complaint reported for part number af5140mbp for leaking.There was no other complaint reported for part number af5140mbp during the same timeframe.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Oxygen was coming through tubing but blowing out of side valve.Bag would not inflate & could not get oxygen to patient.

• 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: 19055616
• Report Number: 1314417-2024-00018
• Device Sequence Number: 18151785
• Product Code: NHK
• UDI-Device Identifier: 10889483074725
• UDI-Public: 10889483074725
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: AF5140MBP
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 448265
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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