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

Model Number	VOCSN-VC PRO, ENGLISH
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by ventec who reviewed the device's electronic records and observed data which confirmed the reported issue of unexpected device reboots.Ventec did not observe any system fault codes in the logs.A deeper dive into the records indicated that during the observed reboots that the internal and external batteries were all showing as not present, which is indicative of them being not installed or depleted.Removal of ac power during these conditions will result in a reboot since the unit will not be able to run on batteries and will restart when ac is reapplied resulting in an abnormal power on listing in the log.Ventec placed both external batteries on a charging station and left the device plugged in ac power overnight.The next day, ventec observed that all batteries had fully charged with no errors.Proper device operation was observed through functional and performance testing.The investigation determined that the root cause of the reported issue was use error due to the user allowing the internal and external batteries to completely deplete (or not be installed), then not allowing the batteries adequate time to recharge prior to plugging the device into ac power and powering it on.
Event or Problem Description
It was reported that the device needed service.Upon evaluation of the device, ventec observed data in the device's memory which indicated that it had previously rebooted multiple times by itself.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 ¿ section d1, brand name, of the initial medwatch report stated: vocsn.Section d1, brand name, of the initial medwatch report should have stated: vocsn-vc.Section d4, model #, of the initial medwatch report stated: prt-00900-001.Section d4, model #, of the initial medwatch report should have stated: vocsn-vc pro, english.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-VC
• 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 16550436
• Report Number: 3013095415-2023-00195
• Device Sequence Number: 6042487
• Product Code: CBK
• UDI-Device Identifier: 00855573007433
• UDI-Public: (01)00855573007433(11)180801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: VOCSN-VC PRO, ENGLISH
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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 Sex: Unknown