Events

Recall of Device Recall Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draegar Medical Systems, 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
    79871
  • Event Risk Class
    Class 2
  • Event Number
    Z-1813-2018
  • Event Initiated Date
    2018-03-28
  • 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=163782
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Software anomaly resulting in the loss of patient settings and stored patient data.
  • Action
    On March 28, 2018, Drager Medical Systems Inc. mailed Urgent Medical Device Recall Notifications to affected customers. The following information was included in the notification: 1) Do not use Infinity MCable Mainstream CO2 sensors revision 16 with M540 Patient Monitor, software versions VG4.1 or lower. Previous revisions of the CO2 sensor may be used. 2) We are in process of resolving this product issue. If you choose to upgrade your system(s), your Dr¿ger service representative will schedule a service visit and upgrade your M540 patient monitor(s) once the updated software is available for distribution. 3)A Customer Reply Card will be included as a receipt from the customers that they received this information and to indicate if the customer would like the revised software update once it is available. Customer with questions regarding the notification may call (800) 437-2437 (press 1 at the prompt, then 32349) Customers with questions regarding the operation and/or servicing of the Drager Infinity Acute Care System may contact Drager Service Technical Support at (800) 437-2437 (press 4 at the prompt then 4 again).

Device

Device Recall Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)
  • Model / Serial
    Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818  UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana Greece Hong Kong Hungary India Indonesia Ireland Italy Japan Jordan Kenya Kuwait Latvia Liechtenstein Lithuania Macedonia Malaysia Maldives Mexico Monaco Mozambique Namibia Netherlands New Zealand Norway Pakistan Panama Peru Poland Portugal Qatar Reunion Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Thailand Trinidad &Tobago; Turkey Turkmenistan United Kingdom USA Utd.Arab.Emir. Vietnam
  • Product Description
    Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, || 4049098009799, 4049098009751. || Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
  • Manufacturer
    Draegar Medical Systems, Inc.

Manufacturer

Draegar Medical Systems, Inc.
  • Manufacturer Address
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA