Rappel de JASMINE Full Body (Patient) Lift

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 Invacare Corporation.

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
    58655
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2741-2011
  • Date de mise en oeuvre de l'événement
    2011-04-01
  • Date de publication de l'événement
    2011-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2013-02-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Lift, patient, - Product Code FNG
  • Cause
    Component defect. the rear mast connector on certain patient lifts distributed by the firm, may break. failure of the rear mast connector, while in use would result in a patient being dropped, possibly resulting in serious injury or death to the patient or care provider.
  • Action
    INVACARE contacted their customers via telephone on 4/8/2011 and 4/11/2011, and informed them of this recall. During these telephone conversations, the customers were asked to immediately cease use of the JASMINE patient lifts and to quarantine all product on-site until further notice from Invacare. The firm followed up on the telephone recall notification with a recall letter dated: April 18, 2011. The recall letter was sent via registered mail or Federal Express so as to verify customer's receipt of the recall notification. The recall letter refers the customer/care provider back to the telephone conversations. and notifies the customer of the possibility of failure of the rear mast connector which could result in a patient's possibly being dropped from the patient lift. The letter asks that the customer remove the suspect patient lift(s) from service and quarantine the device in order to prevent further use until such time as an Invacare Rep. contacts the customer by telephone and makes arrangements to pick-up the affect product. The letter is accompanied by a Response Form and a Product Tracking Sheet which lists all of the JASMINE devices shipped to the customer's facility. The customer is asked to complete the attached Response Form and to fax the form back to Invacare at the telephone number provided on the bottom of the form. The signed Response Form provides information to Invacare documenting the customers receipt of the form and understanding of the instructions contained therein, and also; the number of affected devices remaining on-hand at the customer's location, and the number of devices further distributed by the customer. In those instances in which the products have been further distributed, the customer is asked to 'carry out the instructions of the recalling firm and extend the recall to their sub-account customers.

Device

  • Modèle / numéro de série
    The model number is JASMINE and all serial numberrs are subject to recall.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including DC, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, PA, RI, SC, TN, VA, WA, and WI and the countries of Canada, Ireland, United Kingdom, Norway, Austria, Germany, and Australia.
  • Description du dispositif
    JASMINE Full Body (Patient) Lift, electrically-powered device with a 500 lb. weight capacity. || The recalled product is an electrically-powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-4190
  • Société-mère du fabricant (2017)
  • Source
    USFDA