MAUDE Adverse Event Report: VENTEC LIFE SYSTEMS, INC VOCSN PATIENT BREATHING PACKAGE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ADULT, ACTIVE, HEATED, OXYGEN, BLUE
Medical Device Problem Codes	Material Separation (1562); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the facility advised ventec that the broken patient circuit was disposed of following the event.As a result, it is not available for evaluation.Ventec continues to investigate the reported issue.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
Event or Problem Description
It was reported to ventec that the o2 delivery tube portion of the patient circuit (adult, active, heated, oxygen, blue) had separated from the main tubing assembly.There was patient involvement associated with the reported event.Staff at the facility advised ventec that they initially observed that the ventilator's exhaled tidal volume (vte) levels had dropped by 40-60%, as well as changes in other ventilator parameters (high leak, low tidal volumes, etc.).They further advised that o2 delivery was also impacted for patients who were using the internal concentrator.Staff then observed that the patient circuit was broken and changed it out to resolve the issue.There were no reports of patient harm as a result of the reported issue.No further details about the patient or the event were provided.Ventec has made multiple attempts to obtain additional information about the patient, but no response has been received.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 002 -- section h2, if follow-up, what type?, of supplemental medwatch report 001 stated: device evaluation.Section h2, if follow-up, what type?, of supplemental medwatch report 001 should have stated: additional information.Section h3, device evaluated by manufacturer, of supplemental medwatch report 001 stated: yes.Section h3, device evaluated by manufacturer, of supplemental medwatch report 001 should have stated: no.Section h6, type of investigation, of supplemental medwatch report 001 stated: testing of actual/suspected device (10) and analysis of information provided by user/third party (4112) section h6, type of investigation, of supplemental medwatch report 001 should have stated: testing of device from same lot/batch returned from user (4101) and analysis of information provided by user/third party (4112) section h11, additional manufacturer narrative, of supplemental medwatch report 001 stated: h6: the patient circuit (adult, active, heated, oxygen, blue) was returned to ventec, which was then forwarded on to the supplier for examination.The supplier examined the patient circuit where the reported issue of the o2 delivery tube portion of the circuit separating from the main tubing assembly was confirmed.The supplier observed that the amount of locktite4011 adhesive on the insertion surface of the o2 delivery tube was insufficient, resulting in a relatively weak bonding strength.The investigation determined that the root cause of the reported issue was supplier process due to a lack of adhesive, which created a weak bonding strength.Section h11, additional manufacturer narrative, of supplemental medwatch report 001 should have stated: h6: the broken patient circuit (adult, active, heated, oxygen, blue) had been disposed of following the reported event and therefore was not available to ventec for evaluation.However, the facility was able to provide additional patient circuit¿s from their inventory of the same catalog# and lot# as the circuit in this event for examination.The patient circuit¿s were received by ventec and then forwarded on to the supplier for examination.The supplier examined the patient circuits where the reported issue of the o2 delivery tube portion of the circuit separating from the main tubing assembly was confirmed.The supplier observed that the amount of locktite4011 adhesive on the insertion surface of the o2 delivery tube was insufficient, resulting in a relatively weak bonding strength.The investigation determined that the root cause of the reported issue was supplier process due to a lack of adhesive, which created a weak bonding strength.
Additional Manufacturer Narrative
H6: the patient circuit (adult, active, heated, oxygen, blue) was returned to ventec, which was then forwarded on to the supplier for examination.The supplier examined the patient circuit where the reported issue of the o2 delivery tube portion of the circuit separating from the main tubing assembly was confirmed.The supplier observed that the amount of locktite4011 adhesive on the insertion surface of the o2 delivery tube was insufficient, resulting in a relatively weak bonding strength.The investigation determined that the root cause of the reported issue was supplier process due to a lack of adhesive, which created a weak bonding strength.

• Brand Name: VOCSN PATIENT BREATHING PACKAGE
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• Manufacturer (Section G): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 19934212
• Report Number: 3013095415-2024-00579
• Device Sequence Number: 2847097
• Product Code: CBK
• UDI-Device Identifier: 00850018761062
• UDI-Public: (01)00850018761062(11)231017(10)234202
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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: ADULT, ACTIVE, HEATED, OXYGEN, BLUE
• Device Catalogue Number: PRT-00798-004
• Device Lot Number: 234202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 03/19/2025; 04/02/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 04/02/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Patient Sex: Unknown