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

Model Number	V+C, JAPANESE
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
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
It was reported to ventec by an authorized third party service provider (asp) that the device was rebooting by itself.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
The device was evaluated by ventec where the reported issue of it rebooting by itself could not be duplicated.Ventec downloaded the electronic records (system logs) from the device and confirmed that it had unexpectedly powered off by itself during the previous testing being performed by the authorized third party service provider (asp).Further analysis of the system logs indicated that the device's internal battery had become depleted and that no external batteries were installed, nor was ac power connected, when it logged these "abnormal" power events which are indicative of unexpected losses of power or device rebooting.Ventec ensured that the device's internal battery was fully charged, and that two fully charged external batteries were installed in the device.Proper device operation was observed through functional and performance testing.Based on the information available, it's reasonable to conclude that the cause of the reported issue was user error due to the asp not ensuring that the device's internal and external batteries were fully charged prior to performing their evaluation/testing of the device.

• 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: 20027101
• Report Number: 3013095415-2024-00605
• Device Sequence Number: 8675504
• Product Code: CBK
• UDI-Device Identifier: 00850018761116
• UDI-Public: (01)00850018761116(11)220209
• 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): 07/24/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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