Events

Alerte Ou Avis De Sécurité sur LIFEPAK 20/20e defibrillator/monitor

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Medtronic/Physio-Control.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2010/070
  • Numéro de l'événement
    CON093820
  • Date
    2010-09-09
  • Date de publication de l'événement
    2010-09-09
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON093820?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Due to component failures, which affect ac (mains) and/or dc (battery) operating power, there is a risk that the defibrillator will not deliver therapy.The corrective action programme initiated by the manufacturer will take approximately two years to complete.Problem 1: no dc (battery) operating powercurrent leakage can prevent operation when using dc battery power.  failure of dc power can result in an inability to deliver defibrillation therapy, if no ac power is available. the global failure rate is 0.9% to date.Problem 2: no ac (mains) operating powera component failure prevents ac power operation and prevents battery charging capability. failure of ac power can result in an inability to deliver defibrillation therapy if dc power is depleted.The global failure rate is 0.7% to date.Solutionaffected devices may have problem 1, or problem 2, or both problems. the following phased corrective actions to replace the power supply board have been initiated: phase 1 dc power – identifies devices at a higher risk that accounts for 92% of all dc power failures. the manufacturer expects to complete this phase in 9 to 12 months. phase 2 ac power – identifies the remaining lower risk devices that will be updated upon completion of phase 1. the manufacturer expects phase 2 to take an additional 9-12 months to complete.
  • Action
    1. Assess the need for a back-up or alternative device whilst awaiting corrective action.2. All users should ensure that: they are aware of manufacturer’s Field Safety Notice. the manufacturer’s recommended daily inspection and testing as per the operator’s checklist are performed. where possible, devices are connected to AC mains power and the DC battery kept continuously on charge. 3. The manufacturer has contacted all affected customers. However, if you wish to check if your device is affected, refer to the Field Safety Notice. Be aware of the two year timeline for completion of the corrective action. Assess the need for a back-up or alternative device during this period. If your device exhibits either or both problems, report the failure of the device to the manufacturer and to the MHRA. Arrange for repair of the device with the manufacturer.

Device

LIFEPAK 20/20e defibrillator/monitor
  • Modèle / numéro de série
  • Description du dispositif
    LIFEPAK 20/20e defibrillator/monitor. Specific serial numbers are affected. This is an acute cardiac care device used in clinical and hospital settings. It has a dual power supply system and is designed to operate on AC (mains) power or DC (battery) power. Devices with specific serial numbers, manufactured from 31 July 2002 to 9 February 2009 inclusive, are affected. See the manufacturer’s Field Safety Notice for a list of the relevant serial numbers.
  • Manufacturer
    Medtronic/Physio-Control

Manufacturer

Medtronic/Physio-Control
  • Source
    MHRA