MAUDE Adverse Event Report: VENTLAB LLC VENTLAB; INFANT BAG, NO MASK W/ INFLAT02 RESERVOIR & MANOMETER

Model Number	VN3100OB
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The red fits-all o2 connection does not tightly fit around the bubble connection on the flow elimination during resuscitation would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.
Event or Problem Description
The red fits-all o2 connection does not tightly fit around the bubble connection on the flow eliminator.
Additional Manufacturer Narrative
The red fits-all o2 connection does not tightly fit around the bubble connection on the flow elimination during resuscitation would cause a disruption in resuscitation efforts and patient oxygen saturation decreased product not returned, no images of the issue are provided.Complaint was stated as the fits-all connector was not secure, this is not confirmed.However, replacement inventory was provided.Design history record and inventory cannot be reviewed without a lot number.In the past 24 months, there have been 0 complaints related.Rma-20020, for step r48 states, "product not used properly by user may led to improper function of the device.", causation being "user error- user does not check for proper function before use." s=8, o=2, rpn=16, rc=1.Root cause cannot be determined at this time.However, it is likely this design was not being applied correctly to the other company's design.The fits-all connector, also referred to as universal connector, u-connect, tread grip connector, are designed to either screw onto oxygen diss 1240 fitting or a ¼" (5-7 mm) tapered fitting.This tubing can be used on device that has supple tubing-- nebulizer, resuscitations bags, safety-t, oxygen cannulas, oxygen mask- etc.According to the user guide (ug-20044-c1) in their situation of not attaching tightly they should have used this connector rather than the ribbed end connector.
Event or Problem Description
The red fits-all o2 connection does not tightly fit around the bubble connection on the flow eliminator.
Event or Problem Description
The red fits-all o2 connection does not tightly fit around the bubble connection on the flow eliminator.
Additional Manufacturer Narrative
The red fits-all o2 connection does not tightly fit around the bubble connection on the flow elimination during resuscitation would cause a disruption in resuscitation efforts and patient oxygen saturation decreased.Product not returned, no images of the issue are provided.Complaint was stated as the fits-all connector was not secure, this is not confirmed.However, replacement inventory was provided.Design history record and inventory cannot be reviewed without a lot number.In the past 24 months, there have been 0 complaints related.Rma-20020, for step r48 states, "product not used properly by user may led to improper function of the device.", causation being "user error- user does not check for proper function before use." s=8, o=2, rpn=16, rc=1.Root cause cannot be determined at this time.However, it is likely this design was not being applied correctly to the other company's design.The fits-all connector, also referred to as universal connector, u-connect, tread grip connector, are designed to either screw onto oxygen diss 1240 fitting or a ¼" (5-7 mm) tapered fitting.This tubing can be used on device that has supple tubing-- nebulizer, resuscitations bags, safety-t, oxygen cannulas, oxygen mask- etc.According to the user guide (ug-20044-c1) in their situation of not attaching tightly they should have used this connector rather than the ribbed end connector.**udi related data quality updates only**.

• Brand Name: VENTLAB
• Common Device Name: INFANT BAG, NO MASK W/ INFLAT02 RESERVOIR & MANOMETER
• Manufacturer (Section D): VENTLAB LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, china MI 51917 0; CH 519170
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18252330
• Report Number: 1314417-2023-00028
• Device Sequence Number: 15098626
• Product Code: BTM
• UDI-Device Identifier: 10889483099964
• UDI-Public: (01)10889483099964
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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: VN3100OB
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 11/02/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/12/2024
• 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