Events

Rappel de Device Recall Infinity Acute Care System (lACS) Monitoring Solution

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Draegar Medical Systems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79648
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1382-2018
  • Date de mise en oeuvre de l'événement
    2018-02-21
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162928
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    The invasive pressure visual and audible alarms may not activate.
  • Action
    On February 21, 2018 , Drager Medical Systems Inc. mailed an Urgent Medical Device Recall Notification to affected customers, affected customers that informs the end users of the recommended connecting sequence when using the hemodynamic pod with the M540 patient monitor. A Customer Reply Card will be included as a receipt from the customers that they received and acknowledged the recommended sequence when using the hemodynamic pod with the M540 patient monitor. To avoid encountering the identified issue, the user should follow the below identified steps whenever the hemodynamic pod is plugged into the Infinity M540 patient monitor and the unit is placed in Standby. When the user is ready to monitor the patient: 1. Exit Standby mode 2. Unplug, pause for a minimum of 3 seconds and re-plug the hemodynamic pod 3. Continue per your normal procedure If there are any questions regarding the notification please call 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Drager Infinity Acute Care System (IACS) please contact Drager Service Technical Support at 1-800-437-2437 (press 4 at the prompt and then 4 again). For further questions, please call (978) 379-8077.

Device

Device Recall Infinity Acute Care System (lACS) Monitoring Solution
  • Modèle / numéro de série
    Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, 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 and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.
  • Description du dispositif
    Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, 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 professsionals. 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.
  • Adresse du fabricant
    Draegar Medical Systems, Inc., 6 Tech Dr, Andover MA 01810-2434
  • Société-mère du fabricant (2017)
    Stefan Dräger GmbH
  • Source
    USFDA