MAUDE Adverse Event Report: VENTLAB 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	Low Oxygen Saturation (2477)
Date of Event	04/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was desaturated and was not receiving proper ventilation.
Event or Problem Description
The valve attached to the bvm was not functioning.The doctor was in the process of intubating this patient.The respiratory therapist was trying to bag the patient prior to the doctor placing the tube.The doctor was having some difficulty with the initial tube size.He opted to select a different size.At this time we noticed the patient's oxygen saturation started to drop.The respiratory therapist seemed to be having trouble getting a good seal with the bag valve mask.At this time patient care tech assisted in bagging while the respiratory therapist held a good ce clamp.The tech noticed the bag seemed to be a little easy to squeeze and we did not observe any chest rise while bagging.The patient's oxygen saturation continued to drop.The doctor then finished the intubation.The tech got another bag-valve-mask (bvm) from the omnicell.The patient's oxygen saturation immediately came up into the upper 90s.After completing the intubation staff checked the previous bvm.It appears the valve attached to the bvm was not functioning.It appeared the air coming through the bag entered the valve and came out between the valve and the bag instead of the exiting through the valve into the patient.Staff had saved the bag and turned it over to ed leadership for evaluation.
Additional Manufacturer Narrative
The patient was desaturated and was not receiving proper ventilation.Summary: product was not returned and leak location could not be communicated from the customer.Potential root causes have been shared with the customer.Further investigation cannot be completed without returned devices.Ra: (b)(4) identifies risk id # (b)(4) with severity of 6 for leak to squeeze bag causing a decreased delivery of oxygen.
Event or Problem Description
The valve attached to the bvm was not functioning.The doctor was in the process of intubating this patient.The respiratory therapist was trying to bag the patient prior to the doctor placing the tube.The doctor was having some difficulty with the initial tube size.He opted to select a different size.At this time we noticed the patient's oxygen saturation started to drop.The respiratory therapist seemed to be having trouble getting a good seal with the bag valve mask.At this time patient care tech assisted in bagging while the respiratory therapist held a good ce clamp.The tech noticed the bag seemed to be a little easy to squeeze and we did not observe any chest rise while bagging.The patient's oxygen saturation continued to drop.The doctor then finished the intubation.The tech got another bag-valve-mask (bvm) from the omnicell.The patient's oxygen saturation immediately came up into the upper 90s.After completing the intubation staff checked the previous bvm.It appears the valve attached to the bvm was not functioning.It appeared the air coming through the bag entered the valve and came out between the valve and the bag instead of the exiting through the valve into the patient.Staff had saved the bag and turned it over to ed leadership for evaluation.
Additional Manufacturer Narrative
The patient was desaturated and was not receiving proper ventilation.Summary: product was not returned and leak location could not be communicated from the customer.Potential root causes have been shared with the customer.Further investigation cannot be completed without returned devices.Ra: rma-20020 identifies risk id #r23 with severity of 6 for leak to squeeze bag causing a decreased delivery of oxygen.
Event or Problem Description
The valve attached to the bvm was not functioning.The doctor was in the process of intubating this patient.The respiratory therapist was trying to bag the patient prior to the doctor placing the tube.The doctor was having some difficulty with the initial tube size.He opted to select a different size.At this time we noticed the patient's oxygen saturation started to drop.The respiratory therapist seemed to be having trouble getting a good seal with the bag valve mask.At this time patient care tech assisted in bagging while the respiratory therapist held a good ce clamp.The tech noticed the bag seemed to be a little easy to squeeze and we did not observe any chest rise while bagging.The patient's oxygen saturation continued to drop.The doctor then finished the intubation.The tech got another bag-valve-mask (bvm) from the omnicell.The patient's oxygen saturation immediately came up into the upper 90s.After completing the intubation staff checked the previous bvm.It appears the valve attached to the bvm was not functioning.It appeared the air coming through the bag entered the valve and came out between the valve and the bag instead of the exiting through the valve into the patient.Staff had saved the bag and turned it over to ed leadership for evaluation.

• Brand Name: VENTLAB
• Common Device Name: AIRFLOW ADULT RESUSCITATOR WITH INTEGRATED MANOMETER, B/V FILTER, BAG RESERVOIR,
• 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: 17195277
• Report Number: 1314417-2023-00017
• Device Sequence Number: 7299538
• Product Code: BTM
• UDI-Device Identifier: 10889483074725
• UDI-Public: (01)10889483074725(10)397480
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 06/23/2023

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: AF5140MBP
• Device Catalogue Number: N/A
• Device Lot Number: 397480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 05/25/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/27/2023; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 51 YR
• Patient Sex: Male