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	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to report that the device had stopped ventilating during patient use.Ventec asked the asp for additional information and was provided with the following: ¿when the nurse went to the patient's room after the alarm for decreased ventilation volume and low pressure occurred, she confirmed that the monitor reading was "0".She also confirmed that ventilation had stopped.She started ventilation with an ambu ventilator and replaced it with an alternative ventilator.The patient suffered no harmed [sic].¿ the asp further indicated that the device had logged multiple alarms, including patient circuit disconnect.There was no patient harm as a result of the reported issue.However, medical intervention was required in order to prevent permanent impairment/damage to the patient.
Additional Manufacturer Narrative
H6: the authorized third party service provider (asp) returned the device to ventec.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.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 -- 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).New information for supplemental medwatch report 001 -- h6: the device was evaluated by ventec where the reported issues of no ventilation output and logging a patient circuit disconnect alarm were confirmed.Ventec replaced the blower to resolve the reported issues.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the blower.

• 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: 19706434
• Report Number: 3013095415-2024-00510
• Device Sequence Number: 7751206
• Product Code: CBK
• UDI-Device Identifier: 00855573007761
• UDI-Public: (01)00855573007761(11)201207
• 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): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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
• Date Returned to Manufacturer: 06/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 40 KG
• Patient Race: Asian