Events

Rappel de CARDIOHELPi

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 Maquet Medical Systems USA.

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
    66336
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0082-2014
  • Date de mise en oeuvre de l'événement
    2013-09-12
  • Date de publication de l'événement
    2013-10-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122075
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Cause
    It has come to the attention of maquet that in certain rare instances, the cardiohelp-i device may display an error message with audible alarm, indicating "battery defective." the alarm will occur-upon start up or when the main power supply is unplugged from the main power source. the human machine interface touch screen of the cardiohelp-i device may gradually become black due to the human machine interface (hmi) back light shutting down.
  • Action
    MAQUET issued their customers "Urgent-Medical Device Field Correction" notices/Customer Fax Response forms dated September 16, 2013 via FedEx on September 16, 2013. The notification informs the customer of the issue with the product; how to identified affected product; and the action needed to be taken by the customer. The field correction includes service on the affected product. Authorized MAQUET Service Technicians will service the affected product to correct the issue. Customers were requested to complete and fax back (or email a scanned copy) of the enclosed response form. Customers could contact their local field representative or the MAQUET Customer Service line at 1.888.627.8383 (press option 2 followed by option 2) Monday through Friday, 8am to 6pm EST. For questions regarding this recall call 973-709-7000.

Device

CARDIOHELPi
  • Modèle / numéro de série
    Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533;  90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO
  • Description du dispositif
    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. || Cardiopulmonary support system.
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA
  • Adresse du fabricant
    Maquet Medical Systems USA, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA