Events

Rappel de Device Recall Total Care 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
    57944
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1565-2011
  • Date de mise en oeuvre de l'événement
    2011-02-21
  • Date de publication de l'événement
    2011-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97797
  • 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
    Hill-rom has become aware of a potential issue with some totalcare¿ and versacare¿ beds equipped with the integrated p500 microclimate management (mcm) therapy surface, and with the versacare¿ p500 mcm surface upgrade. because of an unauthorized vendor part modification, it is possible that the mcm blower may not perform as originally designed. given this modification, the mcm blower may experi.
  • Action
    Hill-Rom sent an "IMPORTANT MEDICAL DEVICE CORRECTION" notice dated February 21, 2011, to Facility Risk Manager/Facility Administrators. The letter states that because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate.This issue does not pose a hazard to patients as long as normal patient monitoring is in effect in relation to managing skin temperature and moisture. Customers were instructed to continue to use the product as they normally would. The mattress system would provide an alarm in the event the MCM blower does not operate properly. A Hill-Rom representative would be contacting their facility to make arrangements for correcting the affected MCM blowers. If customers had any questions concerning this request or the procedure as outlined, they were instructed to contact Hill-Rom Technical Support at 800-445-3720. For questions regarding this recall call 812-934-7777.

Device

Device Recall Total Care bed
  • Modèle / numéro de série
    no code.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, CA, CO, CT, DC, DE, FL, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WI, and the countries of ARUBA, AUSTRIA, CANADA, FRANCE, GERMANY, LEBANON, PORTUGAL and SAUDI ARABIA
  • Description du dispositif
    VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN. || The TotalCare¿ Bed Systems 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., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA