Events

Safety Alert for InfinityR Acute Care System (IACS) Monitoring Solution with software versions VG1, VG1.2 and VG1.3

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Drager Medical GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-10-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111013.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: infinityr acute care system (iacs) monitoring solution with software versions vg1, vg1.2 and vg1.3 drager medical gmbh issued a field safety notice in october 2011 to alert healthcare providers and customers of the infinityr acute care system (iacs) monitoring solution with software versions vg1, vg1.2 and vg1.3. wrong drug dosage calculation recommendation and misalignment of ecg and art waveforms on infinity central station are possible to occur. possible wrong drug dosage calculation recommendation according to the manufacturer, the weight-based drug dosage calculation may deliver incorrect recommendation values in the iacs. the failure occurs if the patient’s body weight is not entered via the admin- / demographics screen, but entered via the drug dosage application screen. the failure occurs when entering more than one drug and will apply to the second and all further drug entries until the patient is discharged. the described behavior will not occur if the patient’s weight is correctly entered via the admin- / demographics screen. drager therefore strictly recommends their users to enter the patient’s weight in the admin- / demographics screen on the medical cockpit. possible misalignment of ecg and art waveforms on infinity central station drager has been informed about cases in germany where a misalignment of ecg and art waveforms delivered from an infinityr acute care system (iacs) monitoring solution has been observed on infinity central station. the time discrepancy between the curves observed was in the range of 5-10 seconds. drager recommends their customers to follow the instructions for use and do not consider the waveforms on infinity central station for primary diagnosis purposes. if the misalignment issue is observed, it could be cleared by undocking and redocking of the m540 or by changing the order of waveforms displayed on the cockpit screen (or any other change to the auto display screen layout). the manufacturer also mentioned that a software update will be available later to deal with the problems. according to local supplier, hong kong is affected and the affected customers will be informed. if you are in possession of the affected product, please contact your supplier immediately for necessary actions.

Device

InfinityR Acute Care System (IACS) Monitoring Solution with software versions VG1, VG1.2 and VG1.3
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: InfinityR Acute Care System (IACS) Monitoring Solution with software versions VG1, VG1.2 and VG1.3
  • Manufacturer
    Drager Medical GmbH

Manufacturer

Drager Medical GmbH