Events

Retiro De Equipo (Recall) de Device Recall Model 134, WarmAir Convective Warming Device

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 Cincinnati Sub-Zero Products 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
    59018
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2800-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100840
  • 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
    System, thermal regulating - Product Code DWJ
  • Causa
    A component defect. the recalling firm determined that one of the connectors attached to the firm's warmair 134 device's printed circuit board (pcb) can overheat. should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit.
  • Acción
    CSZ Cincinnati Sub-Zero sent an "URGENT MEDICAL DEVICE RECALL FIELD ACTION" notice to all affected customers. The letter identifies the product, problem, and actions to be taken. CSZ instructs customers to complete and return an enclosed recall response form and to state whether or not their facility is in possession of the device. The completed form should be returned via fax at 513-772-9119 or via e-mail to WA134Recall2011@cszinc.com. Additionally, customers are instructed to discontinue use of the device and return to their Biomedical Engineering and/or Service Department for device exchange and return. Questions regarding this notice are directed to the WarmAir 134 field action (recall) administrator at 1-800-989-7373.

Device

Device Recall Model 134, WarmAir Convective Warming Device
  • Modelo / Serial
    Part #86180, Device Listing #D111865, Serial Numbers: 963-1340100 thru 964-1340199; 971-1340200 thru 971-1340294, 973-1340345 thru 973-1340455; 974-1340445 thru 974-1340594; 981-1340605 thru 981-1340674; 983-1340815 thru 983-1340864; 984-1340905 thru 984-1340964; 991-1341025 thru 991-1341064; 992-1341095 thru 992-1341174; 993-1341265 thru 993-1341274; 994-1341365 thru 994-1341374; 001-1341375 thru 001-1341404; 002-1341405 thru 002-1341414; 003-1341415 thru 003-1341424; and 004-1341425-2 thru 004-1341426-2, are subject to recall**.   **Please Note: CSZ serializes the WarmAir 134 devices beginning with the last two digits of the year manufactured, followed by the quarter of manufacture, the numbers "134" and then a sequential number. For example, a unit with serial number 963-1340100 was manufactured in the third quarter of 1996 with a sequential number of 0100.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the country of Canada.
  • Descripción del producto
    Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. The device draws in room air through a filter by means of an electric blower. It heats the air to the desired temperature by controlling the air temperature entering a flexible connecting hose, and conveys it to the disposable blanket (i.e. FilteredFlow Blankets, Warming Tube) in contact with the patient, in order to warm the patient. || This device provides a continuous flow of heated air as a means of warming patients suffering the common, but significant problems of hypothermia. The system can be used in Post Anesthesia Care Units (PACUs), Intensive Care Units (ICUs), Surgical Intensive Care Units (SICUs), Emergency Rooms (ERs), Operating Rooms (ORs), or any other departments or hospital facilities requiring patient temperature management.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Dirección del fabricante
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    USFDA