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

Model Number	V+O+C+S+N, JAPANESE
Medical Device Problem Codes	Connection Problem (2900); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: ventec will perform an evaluation of the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm and stopped ventilating.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001: section b5, describe event or problem, of the initial medwatch report stated: an authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm and stopped ventilating.There was no patient involvement associated with the reported event.Section b5, describe event or problem, of the initial medwatch report should have stated: an authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm, alarmed due to low inspiratory pressure and then stopped ventilating.There was no patient involvement associated with the reported event.New information for supplemental medwatch report 001: h6: the device was evaluated by ventec where the reported issues of it displaying a patient circuit disconnect alarm, alarming due to low inspiratory pressure and no ventilation output was confirmed.Ventec replaced the blower to resolve the reported issues.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issues was the blower.
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm, alarmed due to low inspiratory pressure and then stopped ventilating.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 002: section d4, model #, of the initial medwatch report stated: prt-01100-100.Section d4, model #, of the initial medwatch report should have stated: v+o+c+s+n, japanese.Section d4, udi #, of the initial medwatch report stated: (b)(4).Section d4, udi #, of the initial medwatch report should have stated:(b)(4).

• Brand Name: VOCSN
• 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17174232
• Report Number: 3013095415-2023-00394
• Device Sequence Number: 12587764
• Product Code: CBK
• UDI-Device Identifier: 00850018761130
• UDI-Public: (01)00850018761130(11)210309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

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: Other
• Device Model Number: V+O+C+S+N, JAPANESE
• Device Catalogue Number: PRT-01100-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 02/23/2026
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 10/27/2023; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown