Events

Alerte De Sécurité sur APS III Model 3500/3510 programming devices (software versions 6.1.1 and earlier) and Merlin PCS Model 3650 programming devices (software versions 4.1.1 and earlier)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par St.

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
  • Date
    2006-10-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20061019.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Software problem found in programming devices for implantable pacemakers the department of health received notification from a medical device manufacturing company about a software problem in two programming devices used by doctors for checking the battery level of pacemakers. the programming devices concerned, produced by st. jude medical inc., are aps iii model 3500/3510 programming devices (software versions 6.1.1 and earlier) and merlin pcs model 3650 programming devices (software versions 4.1.1 and earlier). they are specially designed and made to measure the battery level of the following three pacemaker models manufactured by the same company - identity sr model 5172 identity dr model 5370 identity xl dr model 5376 a spokesman for dh said the software problem may lead to incorrect reporting of battery voltage, expected battery lifespan of the pacemakers and early replacement indicator in the devices. the details can be found at the corporate website of st. jude medical, inc. at www.Sjm.Com . dh has alerted the hospital authority, private hospitals and other relevant medical professional organisations of this safety information. no patient injury or death has been reported so far. the spokesman said patients shall call the hotlines of st. jude medical ( hong kong ) ltd at 2996 7688 from 9 am to 6 pm from monday to friday for enquiries. they can call 9666 4545 or 9777 0097 outside office hours. he reminded patients with these implanted pacemakers to attend scheduled regular check-ups arranged with their doctors. if they have any symptoms of heart disease, they should seek medical attention immediately. end/thursday, october 19, 2006 nnnn.

Device

APS III Model 3500/3510 programming devices (software versions 6.1.1 and earlier) and Merlin PCS ...
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Software Problem Found in Programming Devices for Implantable Pacemakers
  • Manufacturer
    St

Manufacturer

St
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH