Events

Rappel de Philips IntelliSpace ECG Management System

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 Philips 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
    68983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2535-2014
  • Date de mise en oeuvre de l'événement
    2014-08-07
  • Date de publication de l'événement
    2014-08-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129200
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Cause
    Philips intellispace ecg (iecg) management systems that are importing stress ecg records from a quinton stress ecg system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient id (pid), medical record number (mrn). this creates the potential for misdiagnosis and incorrect therapy.
  • Action
    Philips Healthcare sent an Urgent Medical Device Correction Notification / Field Safety notice dated August 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the issue is and under what conditions it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients " the corrective action planned by Philips to address the following issue 1)Previously Imported Stress Records: Institutions that have imported Quinton Stress ECG records into IECG should review each previously imported record to make sure that multiple patient ID data is not present. Institutions that imported stress records at the end of each stress exam or did not batch process the records should not find any records with multiple Patient IDs in the record. However, we do recommend that you perform the review to confirm that multiple Patient IDs do not exist. 2) Continued Use: Software is now available to address the issue described in this letter. If you have not already been contacted by Philips please call to arrange for immediate installation of the software upgrade. The correction will consist of free of charge software upgrade to A.01.06.. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377

Device

Philips IntelliSpace ECG Management System
  • Modèle / numéro de série
    Model No. 860426  Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
  • Description du dispositif
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. || Model No. 860426
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Adresse du fabricant
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA