Events

Recall of SERVO-i/s ventilator systems with software version 8.00.00

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00782-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00782-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Maquet have become aware of improper behaviour introduced in servo-i and servo-s ventilator system sw version 8.00.00. the improper behaviour in system sw version 8.00.00 appears as follows:· if ventilation is started with infant factory default settings, the following settings will apply: pressure control mode; and 10 cmh2o pc above peep.· the system will deliver a pressure of 20 cmh2o above peep as long as the factory default setting 10 cmh2o is used unchanged.For the infant patient category a delivered pressure of 20cmh2o above peep instead of preset 10cmh2o above peep may cause serious injury. the error was discovered at the production site and there are no reported injuries. the issue would be apparent in the pressure curve and peak pressure displayed on the screen.
  • Action
    Maquet is advising users to change the default settings of pressure above PEEP in the infant patient category. The ventilator will only deliver a pressure of 20 cmH2O above PEEP if the default start-up configuration of the pressure has not been changed. A new system software version 8.00.01 is available that will eliminate this behaviour. Maquet has initiated an immediate update of all affected SERVO-i and SERVO-s ventilator systems. This action has been closed-out on 27/01/2017.

Device

SERVO-i/s ventilator systems with software version 8.00.00
  • Model / Serial
    SERVO-i/s ventilator systems with software version 8.00.00Affected devices: SW Service Release v8.00.00 SERVO-I - 68 85 247 and SW Service Release v8.00.00 ERVO-s – 68 85 259ARTG Number: 162468
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA