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

Model Number	V+C+PRO, JAPANESE
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to ventec that the device's lcd display turned black during patient use.There was patient involvement associated with the reported event.There were no reports of patient harm as a result of the reported issue.No further details were provided.Ventec reached out to the reporter to obtain additional information about the patient, however, no response has been received.
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.
Additional Manufacturer Narrative
H6: the initial reporter responded to ventec's request for additional information about the patient and event.As a result, section b3, date of event, has been updated from 1/07/2025 to 12/20/2024.Additionally, sections a2, a3a, a3b, a4 and a6, have been updated accordingly.The reporter further advised that there was no patient harm as a result of the reported issue.Ventec continues to investigate the reported issue and 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.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of a black lcd touchscreen could not be duplicated or confirmed.Proper device operation was confirmed through functional and performance testing.The cause of the reported issue could not be determined.

• 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: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 21140224
• Report Number: 3013095415-2025-00028
• Device Sequence Number: 12641598
• Product Code: CBK
• UDI-Device Identifier: 00855573007211
• UDI-Public: (01)00855573007211(11)180227
• 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: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2025

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: V+C+PRO, JAPANESE
• Device Catalogue Number: PRT-00900-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/15/2025; 02/19/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/11/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2018
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Race: Asian