MAUDE Adverse Event Report: SUNMED HOLDINGS LLC VENTLAB; AIRFLOW ADULT RESUSCITATOR WITH INTEGRATED MANOMETER, B/V FILTER, BAG RESERVOIR,

Model Number	AF5140MBP
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When bag was squeezed no air was being delivered to the patient. patient stats dropped rapidly, recovered fast after switching the bag.Ambu was not functioning properly.Ambu was being squeezed, nut no chest rise volume not being delivered to pt despite oral airway in place and a good seal on a mask on pt's face.Pt was being intubated and pt's desated to 74%, until a new ambu was grabbed from another room and pt's sats increased into the 90's and pt was successfully intubated.Old ambu and bag obtained from room pulled.
Additional Manufacturer Narrative
The bag not providing oxygen while squeezing during intubation delayed therapy to patient would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.
Additional Manufacturer Narrative
The bag not providing oxygen while squeezing during intubation delayed therapy to patient would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.Summary: returned product investigated and found to be in working order.No further investigation required.No applicable risk associated with conforming product.
Event or Problem Description
When bag was squeezed no air was being delivered to the patient. patient stats dropped rapidly, recovered fast after switching the bag.Ambu was not functioning properly.Ambu was being squeezed, nut no chest rise volume not being delivered to pt despite oral airway in place and a good seal on a mask on pt's face.Pt was being intubated and pt's desated to 74%, until a new ambu was grabbed from another room and pt's sats increased into the 90's and pt was successfully intubated.Old ambu and bag obtained from room pulled.
Event or Problem Description
When bag was squeezed no air was being delivered to the patient.Patient stats dropped rapidly, recovered fast after switching the bag.Ambu was not functioning properly.Ambu was being squeezed, nut no chest rise volume not being delivered to pt despite oral airway in place and a good seal on a mask on pt's face.Pt was being intubated and pt's desated to 74%, until a new ambu was grabbed from another room and pt's sats increased into the 90's and pt was successfully intubated.Old ambu and bag obtained from room pulled.
Additional Manufacturer Narrative
The bag not providing oxygen while squeezing during intubation delayed therapy to patient would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.Summary: returned product investigated and found to be in working order.No further investigation required.No applicable risk associated with conforming product.**udi related data quality updates only**.

• Brand Name: VENTLAB
• Common Device Name: AIRFLOW ADULT RESUSCITATOR WITH INTEGRATED MANOMETER, B/V FILTER, BAG RESERVOIR,
• 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: 18068626
• Report Number: 1314417-2023-00025
• Device Sequence Number: 20775671
• Product Code: BTM
• UDI-Device Identifier: 10889483074725
• UDI-Public: (01)10889483074725(10)426087
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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: AF5140MBP
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 426087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 10/05/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 02/15/2024; 07/23/2024
• 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