Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Draeger Medical Systems Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 097 05 18 001
  • Fecha de inicio del evento
    2018-06-27
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12813
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR, FDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Draeger became aware of a device where it was possible to dose 100% n2o. to date, draeger are not aware of any reports of this occurring in devices currently in distribution.The above-mentioned anesthesia machines are equipped with a mechanical o2 minimum dosage module (s-orc). this safety feature prevents the user from inadvertently setting hypoxic gas mixtures (with less than 21% oxygen) at the fresh gas mixer when n2o is selected as one of the carrier gases. draeger investigation determined that the root cause was a burr not being removed from an internal component of the s-orc during the production process.

Device

Fabius, Apollo & Perseus devices
  • Modelo / Serial
    Dräger Fabius, Apollo & Perseus devices with S-ORC Serial Numbers: ASKM-0203 and ASKM-0197 ................................................. FDA update codes: Perseus A500 Anesthesia Machine; Cat. no. MK06000 Codes: ASKM-0197 ASKN-0006 ASKN-0007 ASKN-0008 ASKN-0009 ASKN-0013 ASKN-0014 ASKN-0015 ASKN-0021 ASKN-0026 ASKN-0027 ASKN-0028 ASKN-0029 ASKN-0030 ASKN-0031 ASKN-0034 ASKN-0035 ASKN-0036 ASKN-0037 ASKN-0038 ASKN-0039 ASKN-0040 ASKN-0042 ASKN-0045 ASKN-0046 ASKN-0048 ASKN-0049 ASKN-0050 ASKN-0053 ASKN-0054 ASKN-0055 ASLA-0009 ASLA-0010 Apollo Anesthesia Machine; Cat. no. 8605310 Codes: ASKM-0152 ASKN-0138 ASKM-0193 ASKN-0139 ASKM-0202 ASKN-0143 ASKM-0203 ASKN-0144 ASKM-0211 ASKN-0148 ASKM-0212 ASKN-0150 ASKM-0213 ASKN-0151 ASKM-0214 ASKN-0152 ASKM-0221 ASKN-0163 ASKM-0222 ASKN-0164 ASKM-0227 ASKN-0165 ASKM-0228 ASLA-0001 ASKM-0246 ASLA-0002 ASKM-0269 ASLA-0003 ASKM-0272 ASLA-0092 ASKM-0328 ASLA-0121 ASKM-0332 ASLA-0124 ASKM-0333 ASLA-0131 ASKM-0337 ASLA-0132 ASKM-0339 ASLA-0145 ASKM-0340 ASLA-0146 ASKM-0360 ASLA-0152 ASKM-0362 ASLA-0153 ASKM-0366 ASLA-0154 ASKM-0370 ASLA-0163 ASKM-0371 ASLA-0164 ASKM-0408 ASLA-0165 ASKM-0409 ASLA-0166 ASKM-0415 ASLA-0173 ASKN-0012 ASLA-0174 ASKN-0035 ASLA-0175 ASKN-0039 ASLA-0179 ASKN-0040 ASLA-0180 ASKN-0113 ASLA-0181 ASKN-0114 ASLA-0182 ASKN-0116 ASLA-0183 Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Codes: ASKM-0110 ASKM-0111 ASKM-0196 ASKM-0209 ASKM-0232 ASKM-0244 ASKM-0246 ASKN-0032 ASKN-0033 ASKN-0034 ASKN-0037 ASKN-0041 ASKN-0043 ASKN-0068 ASKN-0093 ASLA-0009 ASLA-0021 ASLA-0023 ASLA-0031 ASLA-0032 ASLA-0123 ASLA-0130 ASLA-0135 ASLA-0136 ASLA-0147 ASLA-0155 ASLA-0158 ASLA-0163 ASLA-0166 ASLA-0170 ASLA-0195 Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Codes: ASLA-0017 ASLA-0018 ASLA-0019 ASLA-0020 Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Codes: ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218
  • Descripción del producto
    Anesthesia Units
  • Manufacturer
    Draeger Medical Systems Inc.

Manufacturer

Draeger Medical Systems Inc.
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Representante del fabricante
    Draeger Arabia Co. Ltd.
  • Source
    SFDA