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

Model Number	PEDIATRIC, ACTIVE, OXYGEN, BLUE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the patient circuit was not returned to ventec for evaluation.The reporter advised that the patient circuit has already been disposed of.The exact date of the event or destruction/disposal of affected product was not known by the reporter.As part of its investigation, ventec examined patient circuits that had been returned by the distributor and had the same part number and lot code as this event.Ventec examined those returned patient circuits and observed that the inner clear tubing had delaminated (detached) from its blue spiral reinforcement.The degree of delamination appeared to vary throughout the length of the circuit based on visual observation and tactile handling of the bond.Ventec contacted the contract manufacturer of the product (supplier) regarding the reported issue.The supplier later advised ventec that it had performed an internal investigation and determined that the product was manufactured using inadequate extrusion temperature.The investigation determined that the cause of the reported issue was a manufacturing error at the supplier.H3 other text : not returned to manufacturer.
Event or Problem Description
Ventec contacted the customer to ensure the receipt and acknowledgement of customer recall notification z-1070-2024 for the vocsn patient breathing package (pediatric, active, oxygen, blue).The customer verbally confirmed receipt of the customer recall notification.During that conversation, the customer notified ventec that the patient circuit had been found to be defective right out of the box, noting that the breathing circuit product coil structure had become delaminated from the circuit tubing.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 -- section d1, brand name, of the initial medwatch report stated: vocsn section d1, brand name, of the initial medwatch report should have stated: vocsn patient breathing package section d4, model #, of the initial medwatch report stated: vocsn section d4, model #, of the initial medwatch report should have stated: pediatric, active, oxygen, blue section d4, udi #, of the initial medwatch report stated: (b)(4).Section d4, udi #, of the initial medwatch report should have stated: (b)(4).Section h5, labeled for single use?, of the initial medwatch report stated: no section h5, labeled for single use?, of the initial medwatch report should have stated: yes.

• 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: 18890666
• Report Number: 3013095415-2024-00231
• Device Sequence Number: 20717849
• Product Code: CBK
• UDI-Device Identifier: 00855573007587
• UDI-Public: (01)00855573007587(11)220307(10)220922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: PEDIATRIC, ACTIVE, OXYGEN, BLUE
• Device Catalogue Number: PRT-00802-001
• Device Lot Number: 220922
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1070-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown