Events

Retiro De Equipo (Recall) de Device Recall TotalCare AC powered adjustable hospital bed

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Hill-Rom, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57733
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1221-2011
  • Fecha de inicio del evento
    2011-02-03
  • Fecha de publicación del evento
    2011-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97268
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA