Events

Rappel de Device Recall CSM1901

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 Nihon Kohden America 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
    76723
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1768-2017
  • Date de mise en oeuvre de l'événement
    2017-03-13
  • Date de publication de l'événement
    2017-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154033
  • 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 pause function on central monitors will not automatically resume when connected to a life scope g9 patient monitor.
  • Action
    A technical bulletin was issued on March 7, 2017 to make Life Scope G9 users aware of following interaction: the CNS 6201A and CNS 9701A (using the noted software versions) will not Auto Resume when a patient is reconnected to a Life Scope G9 if the patient tile is Paused. Therefore, each time a patient is reconnected to the Life Scope G9, the Pause must be cancelled and monitoring manually resumed on the CNS 6201A or CNS 9701A. A customer letter dated March 13, 2017 was sent to all customers to inform them that Nihon Kohden America (NKA) is voluntarily notifying them that the Pause function on central monitors (models CNS 6201A and CNS 9701A; Software Versions 01-06, 02-10 and 02-40), will not automatically resume when connected to a Life Scope G9 patient monitor (model CSM 1901; versions 01-19, 01-20 and 01-21). Customers are informed of issue,risk to health, and instructions. Customers are instructed to complete the attached reply form and return it to the fax number or email address on the form. Customers with questions are instructed to contact NKA Technical Services Group at (800) 325-0283, Option 6 (M-F, 8am-5pm PDT) or by email at G9@nkusa.com.

Device

Device Recall CSM1901
  • Modèle / numéro de série
    Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232)  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software.  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
  • Description du dispositif
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
  • Manufacturer
    Nihon Kohden America Inc

Manufacturer

Nihon Kohden America Inc
  • Adresse du fabricant
    Nihon Kohden America Inc, 15353 Barranca Pkwy, Irvine CA 92618-2216
  • Société-mère du fabricant (2017)
    Nihon Kohden Corp.
  • Source
    USFDA