Events

Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare Ventilator Flexport Interface

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 Spacelabs Healthcare 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
    68374
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1824-2014
  • Fecha de inicio del evento
    2014-05-09
  • Fecha de publicación del evento
    2014-06-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127487
  • 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
    Oximeter - Product Code DQA
  • Causa
    Spacelabs healthcare is voluntarily recalling the hamilton galileo ventilator flexport, model 90436a-07, where the monitored minute volumes (vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
  • Acción
    Spacelabs changed their strategy for updating the software and sent the updated letter Urgent-Medical Device Correction- Hamilton Galileo Ventilator Flexport Model 90436A-07, dated 10 June 2015, to their consignees. The firm is going to send consignees new replacement flexport(s) with upgraded software and requested consignees to return old affected units via Return Goods Authorization (RGA) to Spacelabs and the firm will destroy affected units. Consignees are instructed to take the following actions: 1. Please replace the affected devices and test for correct operation. 2. Return your old device(s) using the RGA number and prepaid FedX shipping label. Use the Reference code: and FedEx Return number: RETURN ADDRESS: Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 (425) 363-5816 If you have any questions about this corrective action program, please call Spacelabs Healthcare at (800) 522-7025 and select 2 for Technical Support. ********************************************************************************************** Spacelabs recommends that customers immediately advise their staff of this situation and if they continue to use the Flexport, to please keep in mind: 1) Galileo Interface Protocol (GIP) version 1.0 and 1.1 do not affect the flexport readings. Only GIP version 1.2 is an issue. 2) If you have the GIP version 1.2: -The ventilator alarms continue to work normally at the bedside and central station. -The ventilator itself is available and working correctly. -The reported x10 volumes would be an obvious error to the clinician. Spacelabs Field Service personnel will be contacting all customers to schedule a convenient time to install, at no cost, a software update that resolves this issue.

Device

Device Recall Spacelabs Healthcare Ventilator Flexport Interface
  • Modelo / Serial
    Serial Numbers Distributed in the US:  436A000660, 436A000663, 436A000664, 436A000666, 436A000667, 436A000669, 436A004306, 436A004307, 436A004308, 436A004309, 436A004310, 436A006122, 436A006123, 436A006441, 436A006442, 436A006443, 436A006444, 436A006452, 436A006573, 436A006589, 436A006590, 436A006591, 436A006592, 436A006593, 436A006594, 436A006595, 436A006596, 6A006597, 436A006598, 436A006599, 436A006600, 436A006601, 436A00670, 436A006966 436A01020, 436A02086, 436A02087, 436A02088, 436A02234, 436A02246, 436A02247, 436A02281, 436A02282, 436A02283, 436A03237 and 436A03238.   Serial Numbers Distributed Outside the US: 436A003628, 436A003629, 436A003630, 436A003631, 436A003632, 436A003633, 436A003634, 436A003635, 436A003636, 436A003637, 436A003638, 436A003639, 436A003640, 436A003644, 436A003645, 436A003646, 436A003647, 436A004162, 436A004166, 436A004197,  436A004198, 436a005205, 436a005471, 436a005472, 436A005638, 436A005641, 436A005642, 436A006087, 436A006088, 436A006151, 436A006193, 436A006248, 436A006249, 436A006250, 436A006262, 436A006389, 436A006390, 436A006397, 436A006445, 436A006446,  436A006522, 436A006523, 436A006524, 436A006570, 436A006571, 436A006572, 436A006609, 436A006610, 436A006611, 436A006612, 436A006613, 436A006614, 436A006616, 436A006617, 436A006618, 436A006619, 436A006620, 436A006621, 436A006624, 436A006625,  436A006950, 436A006951, 436A01023, 436A01094, 436A01095, 436A01096, 436A01097, 436A01098, 436A01099, 436A01100, 436A01101, 436A01102, 436A01103, 436A01104, 436A01105, 436A01106, 436A01107, 436A01108, 436A01129, 436A01152, 436A01190, 436A01191, 436A01192, 436A01193, 436A01194, 436A01195, 436A01197, 436A01199, 436A01200, 436A01212, 436A01213, 436A01217, 436A01298, 436A02023, 436A02024, 436A02025, 436A02026, 436A02027, 436A02188, 436A02233, 436A02262, 436A02264, 436A02590, 436A02591, 436A02592, 436A03193, 436A03239, and 436A03500.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
  • Descripción del producto
    Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Dirección del fabricante
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA