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

Model Number	V+O+C+S+N+PRO, JAPANESE
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the authorized third party service provider (asp) will further evaluate and repair the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.H3 other text : to be serviced by asp.
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to report that the ventilator measured lower peep (positive end expiratory pressure) than set.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the authorized third party service provider (asp) elected to return the device to ventec for evaluation.The device was evaluated by ventec where the reported issue of lower peep (positive end expiratory pressure) than set could not be confirmed during testing.Ventec did, however, observe an issue with the device's internal flow transducer (ift) which warranted its replacement.An issue with the ift could cause the device's peep to fluctuate or be low, therefore the replacement of the ift would resolve any intermittent peep issues.Proper device operation was confirmed through functional and performance testing.Based on the information available, it's reasonable to conclude that the cause of the reported issue was the ift.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 002 ¿ section d4, model #, of the initial medwatch report stated: prt-00490-100 section d4, model #, of the initial medwatch report should have stated: v+o+c+s+n+pro, 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: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 18852707
• Report Number: 3013095415-2024-00208
• Device Sequence Number: 12627055
• Product Code: CBK
• UDI-Device Identifier: 00855573007761
• UDI-Public: (01)00855573007761(11)221102
• 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): 02/15/2024

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+PRO, JAPANESE
• Device Catalogue Number: PRT-00490-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 03/13/2026
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 06/21/2024; 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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