VOCSN recallZ-1902-2021 · Ventec Life Systems, Inc. · initiated May 10, 2021

Why it was recalled

Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.

FDA root cause category: Device Design

What the company is doing

During the week of May 10, 2021, the firm sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter via FedEx or overnight mail to customers informing them that due to malfunctions of the Control Board there is the potential of unexpected shut downs and/or lost of ventilator blower function. As a result, the ventilators may fail to provide ventilation therapy to the patients. Customers are instructed to complete the following clinical action until a replacement unit can be provided: Follow your procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 3. Use an external SpO2 monitor and set the alarm thresholds appropriately if the patient is oxygen dependent. 4. Connect the ventilator to an external monitoring system, wherever possible. In addition, Customers are to acknowledge receipt of the Customer Notification Letter by: 1. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to Ventec within 7 days. 2. Upon receipt of the Customer Response Form, Ventec will arrange shipment of replacement device(s) or arrange repair of existing device(s). 3. Return the affected product to Ventec per instructions and shipping label provided with replacement device(s). Contact Ventec Customer Support at 844-MYVOCSN (844-698-6276) to discuss alternative arrangements, if necessary. If customers are no longer the owner of any of these devices, they need to complete an ownership transfer form at VentecLife.com/tracking so that the Recalling Firm can follow up with the current owner of the impacted device(s). If customers have any question

Recall details

Recall number

Z-1902-2021

Status

Open, Classified

Initiated by the company

May 10, 2021

Posted by the FDA

Jun 21, 2021

Recalling firm

Ventec Life Systems, Inc.

Quantity

1,934 devices (415 device that have not been updated)

Product code

CBK

FDA submissions

K162877

Distribution

Distribution US nationwide, Hong Kong, and Japan

Product description

Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

• VOCSN V+O+C+S+N+Pro, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  3 recalls366 reports
• VOCSN V+O+C+S+N, English

  Ventec Life Systems, Inc. · Ventilator, Continuous, Facility Use
  1 recall286 reports
• VOCSN V+C+Pro, Japanese

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  1 recall33 reports
• VOCSN V+O+C+S+N+Pro, Japanese

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  1 recall32 reports
• VOCSN V+C, English

  Ventec Life Systems, Inc. · Ventilator, Continuous, Facility Use
  1 recall27 reports
• VOCSN V+C+Pro, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  1 recall25 reports

Product lines

• VOCSNVentec Life Systems, Inc. · 17 models · 2,922 reports · 4 recalls

Other devices under the same FDA submission

17 devices cleared under K162877 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• VOCSN V+Pro, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  1 recall570 reports
• VOCSN V+Pro Emergency, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  558 reports
• VOCSN V+Pro, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  2 recalls2 deaths325 reports
• VOCSN V*Home, English

  Ventec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  4 deaths318 reports
• VOCSN V+C+S+N+Pro, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  185 reports
• VOCSN VOCSN, English

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  1 death96 reports
• VOCSN Patient Breathing Package Pediatric, Active, Oxygen, Blue

  Ventec Life Systems, Inc. · Device, Positive Pressure Breathing, Intermittent
  1 recall25 reports
• VOCSN V+C+Pro, Japanese

  Ventec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit
  41 reports
• VOCSN V+C, Japanese

  Ventec Life Systems, Inc. · Ventilator, Continuous, Facility Use
  30 reports
• VOCSN-VC VOCSN-VC Pro, English

  Ventec Life Systems, Inc. · Ventilator, Continuous, Facility Use
  21 reports
• VOCSN Patient Breathing Package Adult, Active, Heated, Oxygen, Blue

  Ventec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  19 reports
• VOCSN V+O+C+S+N, Japanese

  Ventec Life Systems, Inc. · Ventilator, Continuous, Facility Use
  14 reports