Events

Recall of Device Recall Critical Care Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, Inc..

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
    73241
  • Event Risk Class
    Class 1
  • Event Number
    Z-0827-2016
  • Event Initiated Date
    2016-02-04
  • Event Date Posted
    2016-02-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143615
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    The battery capacity of the optional ps500 power supply unit for the infinity (acs) workstation critical and neonatal care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in november 2015 (recall z-0436-2016). the batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
  • Action
    Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available.

Device

Device Recall Critical Care Ventilator
  • Model / Serial
    Catalog #s 8416400 and 8417400
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico.
  • Product Description
    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. || Ventilation.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA