Events

Rappel de Device Recall Arjo Ambulift

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 Arjo, 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
    47885
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1650-2008
  • Date de mise en oeuvre de l'événement
    2008-05-05
  • Date de publication de l'événement
    2008-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-02-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70435
  • 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, Non-AC powered - Product Code FSA
  • Cause
    The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. the resultant fall could result in serious or fatal patient injuries.
  • Action
    Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.

Device

Device Recall Arjo Ambulift
  • Modèle / numéro de série
    Model AB1102 and AB1552, All serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA
  • Description du dispositif
    Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. || Model AB1102 - Standard basic model Ambulift with chair and leg rest. || Model AB1552 - Standard basic model Ambulift with chair and leg rest and scales.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Adresse du fabricant
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA