Events

Alerte Ou Avis De Sécurité sur Bedside model 4170 serial numbers: 1 - 998

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 APC Medical Ltd.

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/2007/095
  • Numéro de l'événement
    CON2033312
  • Date
    2007-12-06
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2033312
  • 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
    Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off. following the investigation of a returned bedside model 4170 temporary cardiac pacemaker, the manufacturer has concluded that there is a potential for rapid pacing to occur when shutting off the device. this can only occur if there is a failure of a specific electronic component within the pacemaker box, and the rapid pace switch is left on. apc medical ltd issued an advisory notice on 09 november 2007 to all affected uk centres. the manufacturer has developed a software modification to eliminate the possibility of rapid pace pulses from occurring on shutdown. they have requested that all affected pacemakers are returned to them for appropriate upgrade. the temporary cardiac pacemaker can be used while awaiting upgrade provided the rapid pace switch is off when shutting down the device.
  • Action
    Check that the rapid pace switch is turned off before shutting down the device. Identify all pacemakers with serial numbers 1 - 998 and return to APC Medical Ltd for a software upgrade. Contact APC Medical Ltd customer service department for information on how to schedule the return of your device(s) for upgrade.

Device

Bedside model 4170 serial numbers: 1 - 998
  • Modèle / numéro de série
  • Description du dispositif
    External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 - 998. Manufactured by APC Medical Ltd. The APC Bedside model 4170 single chamber external temporary cardiac pacemaker is designed in the USA by Pace Medical Inc., produced in the UK by APC Medical Ltd and supplied to UK hospitals by APC Cardiovascular.
  • Manufacturer
    APC Medical Ltd

Manufacturer

APC Medical Ltd