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

Model Number	AF5140MB
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient disconnected from the ventilator and placed on ambu bag by anesthesia resident team.Patient moved out of operating room and down h hallways to transfer to icu.Between h and g it was noted the patient was desaturating and the vital signs were beginning to decompensate.At this time, it was noted the ambu bag was not ventilating the patient.All connection and oxygen supply were verified and checked.A resident ran to the operating room to get a new ambu bag and the team rushed the patient back into the operating room.The new ambu bag appeared to functioning properly.Ventilation was verified by auscultation and he was ventilated until oxygen saturations improved.The patient was then transferred to the icu without issue.
Additional Manufacturer Narrative
Ventilation was compromised and the patient was deemed hypoxic.The bvm malfunctioning would potentially lower the volume delivered to the patient.Based on the reported information, the criteria for reporting an adverse event have been met.
Additional Manufacturer Narrative
Ventilation was compromised and the patient was deemed hypoxic.The bvm malfunctioning would potentially lower the volume delivered to the patient.Based on the reported information, the criteria for reporting an adverse event have been met summary: returned product confirms complaint.Product was found to be missing a duckbill valve which prevented any pressure to be delivered to the patient port.Customer notified of defect, mitigation process outlined in ifu, and defect rates.Ra: risk assessment review of rma-20020, r37 identifies that missing components (like the tail assembly umbrella valve) are associated with a severity of 7.
Event or Problem Description
Patient disconnected from the ventilator and placed on ambu bag by anesthesia resident team.Patient moved out of or and down h hallways to transfer to icu.Between h and g it was noted the patient was desaturating and the vital signs were beginning to decompensate.At this time, it was noted the ambu bag was not ventilating the patient.All connection and oxygen supply were verified and checked.A resident ran to the or to get a new ambu bag and the team rushed the patient back into the or.The new ambu bag appeared to functioning properly.Ventilation was verified by auscultation and he was ventilated until oxygen saturations improved.The patient was then transferred to the icu without issue.

• Brand Name: SUNMED LLC
• Common Device Name: SMALL ADULT AIRFLOW W/MANOMETER
• Manufacturer (Section D): SUNMED LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED 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: 16114398
• Report Number: 1314417-2023-00001
• Device Sequence Number: 20295230
• Product Code: BTM
• UDI-Device Identifier: 10889483103012
• UDI-Public: 10889483103012
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/06/2023

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/06/2023
• 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