Events

Retiro De Equipo (Recall) de Device Recall TotalCare

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
    76506
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1816-2017
  • Fecha de inicio del evento
    2017-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153395
  • 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 bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.
  • Acción
    On 2/23/2017, URGENT: MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers without a service contract received the following instructions: Action to be taken by the user: A software update for the TotalCare¿ beds GCI has been released to resolve this issue. Enclosed with this letter are a USB stick with the updated software, instructions on how to update the GCI software, and a response form to be returned within 30 days. 1) Identify any affected TotalCare¿ beds with 3-Level Patient Position Monitoring in your facility by using the criteria above. 2) Please use the enclosed instructions and update the software on each potentially affected TotalCare¿ bed immediately. 3) Record the serial numbers of the beds being updated on the response form and return to Hill-Rom within 30 days of receipt of this letter. Additional USB sticks with the updated software may be obtained by contacting Technical Support at 1-800-445-3720 (select Option 2, then Option 2 again). Until each of the affected TotalCare¿ beds are updated with the new software, we recommend you do one or more of the below to avoid any potential occurrences of bed exit not functioning. 1. Power cycle (unplug and plug in the bed mains power cord) once every 48 hours. 2. Remove the Patient and re-zero the scale once every 48 hours. 3. Turn off and do not use the Bed Exit Alarm functionality. Continued use of the bed exit alarm without the mitigations listed above may cause risk to patient. If you have an upgrade kit (P1957A) that has not been installed, please contact Hill-Rom for return and replacement. Customers with a service contract received the following instructions: Action to be taken by the user: A Hill-Rom representative per

Device

Device Recall TotalCare
  • Modelo / Serial
    P1900 SN: K328AM6065 to Q245AM0691 PR1900  SN: L082AL7316 to R343AL4516 U1900  SN: L257AM0541 to O311AM7169 Scale Upgrade Kit P1957A produced after March 13, 2013 (not serialized).
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS
  • Descripción del producto
    TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Dirección del fabricante
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA