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

Model Number	V+C, JAPANESE
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to report that the device was unable to maintain peep (positive end expiratory pressure).There were no reports of patient involvement associated with the reported event.
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.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 -- section d4, model #, of the initial medwatch report stated: prt-01098-100.Section d4, model #, of the initial medwatch report should have stated: v+c, 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).New information for supplemental medwatch report 001 -- h6: the device was not returned to ventec for evaluation.The device was further evaluated by the authorized service provider (asp) where the reported issue of the ventilator being unable to maintain peep (positive end expiratory pressure) could no longer be duplicated or confirmed.The asp advised ventec that they determined that the waveform was abnormal due to leakage from the test lung and not due to a device malfunction.Proper device operation was confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was asp operator error and not the result of a device malfunction.

• 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: 19716579
• Report Number: 3013095415-2024-00516
• Device Sequence Number: 15526466
• Product Code: CBK
• UDI-Device Identifier: 00850018761116
• UDI-Public: (01)00850018761116(11)210317
• 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: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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+C, JAPANESE
• Device Catalogue Number: PRT-01098-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2021
• 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