Events

Alerte De Sécurité sur expression information portal - ip5

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.

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
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • 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_20131016a.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 expression information portal - ip5 the therapeutic goods administration (tga), australia issued a medical device safety alert concerning expression information portal - ip5, manufactured by philips. the affected product number is 865471 and the affected serial numbers are us23200375, us23200376, us23200377. if the affected product is in use or powered on for an extended period of time (exceeding 24 hours), it may lost all audio function. "all audio" includes touch screen and qrs/spo2 modulation tones and audible alarms. all other functionality of the affected product is unaffected (waveforms, numeric values, visual alarm indications). the manufacturer will contact the affected customer to arrange for a software update to correct the problem. end users are requested to power cycle the affected product once every 24 hours and to be aware not to rely solely on audible alarms for alerting of potentially critical patient events. .According to the local supplier, the affected products were not distributed in hong kong. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01052-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

expression information portal - ip5
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Expression Information Portal - IP5
  • Manufacturer
    Philips

Manufacturer

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