Events

Rappel de Device Recall Excel Care Bariatric Bed

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 Hill-Rom, 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
    55301
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0332-2011
  • Date de mise en oeuvre de l'événement
    2010-03-05
  • Date de publication de l'événement
    2010-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90505
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Cause
    The firm received complaints regarding the siderails not operating correctly or becoming inoperable. the siderails could experience false latching, unintentional lowering or become inoperable. there have been reports of 5 patient falls and 2 injuries to caregivers.
  • Action
    Hill-Rom sent out "Urgent Medical Device Correction" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail. If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.

Device

Device Recall Excel Care Bariatric Bed
  • Modèle / numéro de série
    XL100092, XL100091, XL100077, XL100124 and XL101363.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA states including: AK, FL, HI, IN, KS, LA, MS, OK, PA, TN, VT, and WA and countries including: Canada, Mexico, Angola, Australia, Saudi Arabia, Qatar, and United Emirates.
  • Description du dispositif
    Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN. || Intended Use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed supports patients between 250 and 1000 pounds.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA