Alerte De Sécurité sur Monitors of Electrocardiography. Electrocardiographic Monitoring Modules: (1) Model 90342, (2) Model 90344, (3) Model 90346, (4) Model 90348, (5) Model 90470, (6) Model 90478, (7) Model 90496

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Spacelabs Medical Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
  • Cause
    An anomaly, which fails to detect low heart rates at a frequency of 12 to 15 beats per minute, may exist in the electrocardiographic monitoring module above. for this anomaly to occur, three things have to occur simultaneously: (1) the heart rate has to fall suddenly within a beat interval. (2) the rhythm of the heart has to fall within the oscillation of 12 to 15 beats per minute. (3) the heart's rhythm must remain within the oscillation of 12 to 15 beats per minute. in this condition, the software will not update, detect the change or may generate a low-beat alarm. there were no injuries or deaths in patients associated with this anomaly and any heart rate outside of this range will provide an appropriate alarm. the manufacturer initiated a field correction through a letter dated october 22, 2001, called the emergency medical device corrective action.
  • Action
    Make sure you have received Spacelabs' October 22, 2001 letter Identify and isolate any affected product in your inventory. Spacelabs is offering replacement software to correct the anomaly associated with the above modules. If you have the drives with models No. 90342, 90344, 90346, 90348, 90470, or 90478 in your inventory, the manufacturer is offering the opportunity to do an upgrade on its own. If you choose this action, you must sign up to be included in the program. The manufacturer will then provide, free of charge, the upgrade software for each affected unit and instructions on how to make the upgrades. After you complete and sign an installation modification report for each affected module and return the affected software for each module, you will receive $ 25 of credit in your account for each updated model, valid for maintenance or purchase of products within 12 months. For customers who choose not to participate in this opportunity or if you have the model no. 90496 upgrade software will be installed by the on-site representative of Spacelabs at no charge. The manufacturer estimates that each update will take about 30 minutes. Until your ECG modules are up-to-date the manufacturer recommends that you be aware of the above-mentioned anomaly to prevent any adverse events from happening. For more information, contact your local representative or directly with Spacelabs Technical Monitoring Support by phone 1 (206) 882-3700 in the USA.


  • Source