Events

Rappel de Device Recall TotalCare SpO2RT 2 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
    64580
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0949-2013
  • Date de mise en oeuvre de l'événement
    2013-02-26
  • Date de publication de l'événement
    2013-03-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116540
  • 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
    In certain situations a software problem with the totalcare spo2rt¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. this may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. a correction to the software program is currently being developed and tested,.
  • Action
    Hill-Rom sent an Urgent Field Safey Notice letter dated February 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter advised customers to follow steps provided until the updated software is available. Customers were requested to forward a copy of this letter to any other facility personnel you deem appropriate. Questions should be directed to Hill-Rom Technical Support at 800-445-3720

Device

Device Recall TotalCare SpO2RT 2 bed
  • Modèle / numéro de série
    S/N between N230AM1358 & O023AM3687.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution including the state of Canada
  • Description du dispositif
    TotalCare SpO2RT2 bed. || Product Usage: || Bed, flotation therapy, powered bed 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 SpO2RT¿ 2 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 Route 46 East, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA