Events

Retiro De Equipo (Recall) de Cardiovascular blood flowmeter

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 Parks Medical Electronics, 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
    63235
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0443-2013
  • Fecha de inicio del evento
    2012-08-08
  • Fecha de publicación del evento
    2012-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113079
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    Parks medical electronics, inc. was made aware of two incidents where an air supply tube from their parks pvr unit was inadvertently connected to an iv in the patient's arm instead of into the blood pressure cuff.
  • Acción
    The firm, Parks Medical Electronics, Inc., sent an "IMPORTANT SAFETY ISSUE SERIOUS HEALTH CONSEQUENCE" letter, dated September 10 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers are advised to order LUER UPGRADE KIT WITH MPI if the Parks device includes a Multi Port Inflator (MPI), and/or order the LUER UPGRADE KIT WITHOUT MPI the Parks device does not have a Multi Port Inflator. While waiting for the kit or its installation, consignees/customers should use extreme caution when hooking up the air supply tubes to the cuff's Luer fittings. For ordering your kit, please call 800-547-6427 option 0. For responses, questions or concerns, customer should contact Parks Medical Electronics at 888-356-9522 (Phone), 503-591-9753 (Fax) or send email to support@parksmed.com.

Device

Cardiovascular blood flowmeter
  • Modelo / Serial
    Domestic Distribution: 013053, 013104, 013107, 013124, 013154, 013182, 013193, 014203, 014237, 014248, 014249, 014252, 014253, 014254, 014269, 014276, 014310, 014335, 014339, 014361, 014366, 014376, 014380, 014381, 014382, 014384, 014397, 014401, 014406, 014416, 014424, 014429, 014431, 014443, 014444, 014448, 014454, 014458, 014530, 014532, 014533, 014540, 014542, 014545, 014547, 014551, 014552, 014552, 014553, 014598, 014601, 014604, 014608, 014616, 014654, 014657, 014659, 014660, 014661, 014663, 103077, 105X-600001024, 105X-600001025, 105X-600001026, 105X-600001027, 105X-800001019, 105X-800001022, 105X-800001023, 105X-800001024, 105X-800001026, 105X-800001027, 105X-800001027, 105X-800001028, 105X-800001029, 105X-800001030, 105X-800001031, 105X-E00001001, 105X-E00001002, 105X-E00001003, 105X-E00001004, 105X-E00001005, 105X-E00001007, 105X-E00001008, 105X-E00001009, 105X-E00001010, 105X-E00001011, 105X-E00001012, 105X-E00001013, 105X-E00001014, 105X-E00001016, 105X-E00001017, 105X-E00001018, 105X-E00001019, 105X-E00001020, 105X-F00001000, 105X-F00001001, 105X-F00001002, 105X-F00001003, 105X-F00001004, 105X-F00001005, 105X-F00001005, 105X-F00001006, 105X-F00001007, 105X-F00001008, 105X-F00001009, 105X-F00001010, 105X-F00001011, 105X-F00001012, 105X-F00001013, 105X-F00001014, 105X-F00001015, 105X-F00001016, 105X-F00001017, 105X-F00001018, 105X-F00001020, 105X-F00001021, 105X-F00001022, 105X-F00001023. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify. Foreign distribution: 01301, 013043, 013044, 013045, 013046, 013072, 013076, 013175, 013181, 013183, 013188, 014215, 014386, 014392, 014393, 014456, 014535, 014550, 014551, 014561, 014562, 014563, 105X-800001025, 105X-922001017, 105X-922001018, 105X-922001019, 105X-922001021, 105X-9221020, 105X-923001001, 105X-923001002, 105X-923001003, 105X-923001004, 105X-923001005, 105X-923001006, 105X-923001007, 105X-923001007, 105X-923001009, 105X-923001010, 105X-923001011, 105X-E00001000, 105X-E00001003, 105X-E00001006, 105X-E00001015, 105X-F00001019. There are also devices that pre-dated bar codes, as well as devices with unknown codes that the firm is unable to identify.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, Egypt, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Mexico, Peru, Republica Argentina, Spain, Switzerland, and Venezuela.
  • Descripción del producto
    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. || Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) || All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.
  • Manufacturer
    Parks Medical Electronics, Inc

Manufacturer

Parks Medical Electronics, Inc
  • Dirección del fabricante
    Parks Medical Electronics, Inc, 19460 SW Shaw St, Aloha OR 97007-1242
  • Empresa matriz del fabricante (2017)
    Parks Medical Electronics Inc
  • Source
    USFDA