Events

Rappel de Device Recall TotalCare AC powered adjustable hospital 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
    57733
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1221-2011
  • Date de mise en oeuvre de l'événement
    2011-02-03
  • Date de publication de l'événement
    2011-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97268
  • 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 one report that a patient was weighed on the bed at 53 kg when the patient actually weighed 73 kg. the patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. the firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.
  • Action
    The firm, Hill-Rom, sent a "URGENT MEDICAL DEVICE CORRECTION" letter dated January 19, 2011, along with a software upgrade (USB stick/flash drive) with instructions, to all affected customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to requests that facility service personnel immediately upgrade their software; complete and return the Customer Response Form via fax to 812-931-2410 or mail to: Hill-Rom Company, 1069 State Route 46 E, Batesville, IN 47006, Attn: MOD Coordinator J12 and forward a copy of this notice to any other facility personnel. Note: The customer can request that Hill-Rom technicians complete the software upgrade. If you have any questions concerning this Urgent Medical Device Correction, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Device Recall TotalCare AC powered adjustable hospital bed
  • Modèle / numéro de série
    J106AM7237, J107AM7243, J107AM7249, J115AM7361, J115AM7365, J115AM7368, J084AM6731, J084AM6737, J085AM6756, J085AM6760, J084AM6723, J095AM7019, J098AM7041, J084AM6747, J086AM6812, J114AM7341, J156AM7992, J085AM6757, J086AM6792, J086AM6796, J086AM6806, J086AM6806, J091AM6906, J091AM6919, J095AM7014, J101AM7145, J114AM7342, J116AM7391, J119AM7400, J130AM7605, J148AM7842, J148AM7844, J148AM7848, J162AM8078, J163AM8107, J113AM7335, J113AM7336, J127AM7535, J127AM7542 and J133AM7621.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: AUSTRALIA, BRAZIL, CANADA, CHINA, EGYPT, GERMANY, GREECE, ITALY, JAPAN, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, OMAN, POLAND, QATAR, SAUDI ARABIA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, VENEZUELA, and YEMEN.
  • Description du dispositif
    Hill-Rom TotalCare Bariatric Bed, P1840, Hill-Rom, Batesville, IN. || TheTotalCare Bed System is intended to porvide 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).
  • 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