Events

Rappel de Device Recall TotalCare 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
    65259
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1794-2013
  • Date de mise en oeuvre de l'événement
    2013-05-30
  • Date de publication de l'événement
    2013-07-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118400
  • 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, flotation therapy, powered - Product Code IOQ
  • Cause
    When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. a patient attempting to get back into the bed may miss the seat and sit on the foot section instead. the patient can slide down to the floor, or fall, with possible injury.
  • Action
    The firm, Hill-Rom, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 29, 2013 was sent to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Until the correction is implemented, after placing the bed into chair position, regularly check the foot section of the mattress. If necessary, push it back against the bed frame until the magnets hold it in place before allowing the patient to get back into or out of bed. In addition, forward a copy of this letter to any other facility personnel you deem appropriate. If you have any questions concerning this notification, please contact your distributor, your Hill-Rom representative, or Hill-Rom Technical Support at 800-445-3720 (Mon-Thurs, 8 am-6:30 pm; Friday, 8 am-6 pm).

Device

Device Recall TotalCare Bed
  • Modèle / numéro de série
    Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384.   The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
  • Description du dispositif
    TotalCare Bed used with AccuMax Quantum VPC mattress || AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress || The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA