MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; SMALL ADULT AIRFLOW W/MANOMETER

Model Number	AF5140MB
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	08/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The air leaking during intubation delayed therapy to patient would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.
Event or Problem Description
Air leaking during intubation, not delivering the patient o2. occurred during patient use, possible delay in treatment.
Additional Manufacturer Narrative
The air leaking during intubation delayed therapy to patient would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.The complaint of "air leaking during intubation, not delivering the patient o2." regarding part number af5140mb/lot 428861 was confirmed.Returned product was investigated.Visual inspection identified a loose diaphragm valve within the bag body and it was concluded that the diaphragm valve was not assembled correctly and became loose prior to end-use.A risk assessment was performed, and the ultimate risk was determined to be high which does require reporting to the capa review board; the complaint was submitted to carb and they decided to open a capa (capa-00513) for this issue.There have been two (2) other confirmed complaints regarding part number af5140mb for the same issue within the 24 months preceding the reporting of this issue.A memo, containing the complaint investigation, was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Air leaking during intubation, not delivering the patient o2. occurred during patient use, possible delay in treatment.

• Brand Name: SUNMED LLC
• Common Device Name: SMALL ADULT AIRFLOW W/MANOMETER
• 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: 17795871
• Report Number: 1314417-2023-00020
• Device Sequence Number: 2251179
• Product Code: BTM
• UDI-Device Identifier: 10889483103012
• UDI-Public: 10889483103012
• Combination Product (Y/N): N
• 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): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AF5140MB
• Device Catalogue Number: AF5140MB
• Device Lot Number: 428861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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