Events

Rappel de A5 ANESTHESIA DELIVERY SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19731
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-07-17
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Mindray has become aware of the potential for a software anomaly to manifest on the a-series anesthesia system. no adverse patient event was reported. this potential issue is related to the system's electrically erasable programmable read-only memory (eeprom) and will only occur if the system's total number of write cycles to a particular range of memory locations has exceeded the life specification of the eeprom. the issue will only manifest at start up or at the end of a case.It will not occur during a case.Two scenarios may occur resulting from this issue.1) the unit will not be able to enter standby mode when the user confirms "discharge" (in software bundle version < 02.06.00) or "end case" (in software bundle version > 02.06.00) in the dialog box. under these conditions the unit can only enter the standby mode by manually unchecking "restore default settings" in the same dialog box.When the "restore default settings" in the dialog box is unchecked the previous settings will be applied to the next case instead of the user established default settings.If left unaddressed for a period of time this second scenario will be encountered.2) at startup the unit will automatically skip over the startup leak test as well as standby mode and immediately enter either manual or automatic ventilation mode depending on the position of the manual/auto switch.This potential issue affects a-series systems with software bundle version 02.02.00 through 02.11.00 and some units with 02.11.01.

Device

A5 ANESTHESIA DELIVERY SYSTEM
  • Modèle / numéro de série
    Model Catalog: 0631B-PA00012 (Lot serial: 0.02.00-02.11.00 SOFTWARE); Model Catalog: 0632B-PA00014 (Lot serial: )
  • Description du dispositif
    A-Series (A5/A7) Anesthesia Delivery System
  • Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

Manufacturer

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.