Events

Recall of Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2014-RN-01245-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01245-1
  • 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
    If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (pcba) and short to ground which may prevent the ventilator to switch to battery power if ac power is disrupted. a high urgency audible alarm will sound alerting medical personnel of the loss of power. in the absence of ac power, failure of battery power will cause loss of ventilator support which could result in hypercarbia or hypoxemia.
  • Action
    Philips is advising their customers to carry out a Power Fail Alarm Test as per the Operators Manual. If AC power is disrupted and the ventilator cannot switch to battery operation, a High Urgency alarm will sound and the patient must be supported with another means of life support ventilation. A new fan installation hardware kit will be installed on affected units. A Philips Field Service Engineer will be contacting customers to schedule the installation at no-cost. This action has been closed-out on 12/08/2016.

Device

Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics
  • Model / Serial
    Esprit V1000 and Esprit/V200 Conversion VentilatorRespironics Part Numbers: 701-01000-00, C701-01000-00, DU701-01000-00, U701-01000-00Philips Part numbers : 989805611721, 989805643301, 989805612621, 989805613441ARTG Number: 134845
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA