Events

Alerte De Sécurité sur mrx lithium ion batteries

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

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
    2014-02-20
  • Date de publication de l'événement
    2014-02-20
  • 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/recalls_20140220.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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: philips heartstart mrx lithium ion batteries medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning heartstart mrx lithium ion batteries with battery model number m3538a revision j and the affected battery serial numbers are: 11327-0019-p, 11315-0023-p, 11315-0027-p, 11315-0031-p, 11315-0032-p, 11315-0033-p, 11315-0036-p, 11315-0109-p, 11315-0214-p, 11315-0219-p, 11315-0391-p, 11322-0084-p, 11322-0088-p, 11327-0043-p, 11327-0044-p; or within range 11335-xxxx-p to 13214-xxxx-p according to the manufacturer, the philips heartstart mrx monitor/defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from radio frequency (rf) energy sources. examples of equipment that can cause electromagnetic interference are medical devices, cellular products, information technology equipment and radio/television transmissions. the manufacturer provides users with the following information and advice: the condition can be avoided by operating the device on ac or external dc power or by the following actions when operating on battery power: 1) before placing a heartstart mrx into use, insert a fully-charged battery with five solid green lights on the battery fuel gauge when the fuel gauge button is pressed; 2) if the device does not power on, press the fuel gauge button and verify that at least one solid green light is illuminated. if there are no lights, insert a fully-charged mrx battery fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. the manufacturer advises users to see the heartstart mrx instructions for use for the minimum recommended separation distance between rf communications equipment and the heartstart mrx. furthermore, the manufacturer will replace affected batteries. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 february 2014.

Device

mrx lithium ion batteries
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips HeartStart MRx Lithium Ion batteries
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH