Events

Rappel de Infinity(R) Acute Care System (IACS) Monitoring Solution (M540)

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 Draeger Medical, 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
    60155
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0263-2012
  • Date de mise en oeuvre de l'événement
    2011-10-18
  • Date de publication de l'événement
    2011-11-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104618
  • 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
    During product training on the infinity(r) acute care system (iacs) monitoring solution (m540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. in addition, a misalignment of ecg and art waveforms delivered from an infinity(ro acute care system (iacs) monitoring solution (m540) was observed on the infinity central station.
  • Action
    The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, "Check the patient and treat if necessary". If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed on the Cockpit screen (or any other change to the auto display screen layout).

Device

Infinity(R) Acute Care System (IACS) Monitoring Solution (M540)
  • Modèle / numéro de série
    Catalog number MS25510
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution - IL
  • Description du dispositif
    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution || Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Adresse du fabricant
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Société-mère du fabricant (2017)
    Stefan Dräger GmbH
  • Source
    USFDA