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	Use of Device Problem (1670); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the authorized third party service provider (asp) will further evaluated and repair 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 the device had low inspiratory pressure.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: ventec has determined that this medwatch report was submitted in error.The reported issue of low inspiratory pressure was incorrect.The initial reporter, an authorized service provider (asp), was performing preventative maintenance on the device and failed to allow it adequate time to warm up prior to testing.Once the device warmed up, proper device operation was confirmed.As a result, this does not meet reportability requirements as the issue would not cause or contribute to death or serious injury if it were to recur.

• 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: 19811958
• Report Number: 3013095415-2024-00534
• Device Sequence Number: 15327588
• Product Code: CBK
• UDI-Device Identifier: 00850018761130
• UDI-Public: (01)00850018761130(11)220120
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: Other
• Device Model Number: V+O+C+S+N, JAPANESE
• Device Catalogue Number: PRT-01100-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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