Events

Recall of INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGERWERK AG & CO. KGAA.

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
    15486
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Draeger became aware about an event in which the battery capacity of the optional ps500 of an iacs workstation critical care (evita infinity v500) did not last as long as expected. the batteries installed in the ps500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. the sequential alarms "battery low" followed by "batter depleated" were given however the remaining time until the ventilator shut down was not foreseeable. when the battery depleted totally the power fail alarm was generated. draeger issued a measure in february 2014 and july 2014 regarding battery capacity failures. the root cause for the reduced battery capacity at that time was due to an incorrect charging algorithm that subsequently caused sulfation within the battery. the new battery that was exchanged with that corrective action was tested and qualified. however draeger has learned from the supplier that the batteries of this lot may be affected by a manufacturing defect that may lead to shorter battery life times. as a consequence draeger has decided to replace all batteries for the ps500 again.

Device

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500
  • Model / Serial
    Model Catalog: 8415000 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500
  • Manufacturer
    DRAEGERWERK AG & CO. KGAA

Manufacturer

DRAEGERWERK AG & CO. KGAA