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

Model Number PRT-01100-000

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by ventec where the reported issue of the alarm for very low fio2 (fraction of inspired oxygen) levels was confirmed.Ventec's investigation determined that the root cause of the reported issue was that the device, which was supposed to be configured as a vocsn standard, had been configured as a vocsn pro during the manufacturing process.As a result of the device's software configuration (vocsn pro), it displayed an option for high pressure external oxygen under oxygen therapy which is only available in a pro configuration.The device then alarmed indicating that fio2 was very low because it was trying to activate a pro function not available to a standard device.Ventec then installed the appropriate vocsn standard configuration software and proper device operation was then observed through functional and performance testing.This mdr has been reassessed as reportable after conducting a retrospective review of prior complaint records.As this has been reassessed, it will appear to be a late mdr.

Event Description

It was reported to ventec that the that the device alarmed, indicating very low fio2 (fraction of inspired oxygen) levels.There was no patient involvement associated with the reported event.

• Brand Name: VOCSN
• Type of Device: 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: 12457723
• MDR Text Key: 270994071
• Report Number: 3013095415-2021-00279
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRT-01100-000
• Device Catalogue Number: PRT-01100-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1