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Alerte De Sécurité sur IntelliVue Information Center and Philips IntelliVue Information Center iX
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
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Date
2012-12-07
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Date de publication de l'événement
2012-12-07
- Pays de l'événement
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Source de l'événement
DH
- URL de la source de l'événement
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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
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Cause
Medical device safety alert: philips intellivue information center and philips intellivue information center ix medical device supplier, philips healthcare, has issued a medical device safety alert regarding philips intellivue information center and philips intellivue information center ix. this issue affected all piic and piic ix products using hewlett packard rp5800 pcs. philips has identified that an internal audio cable connector may have diminished retention force due to damaged contacts. this diminished retention force could lead to intermittent or loss of audible alarms. failure to annunciate audio alarms may delay recognition of an alarm condition, if users do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system, e.G., a bedside monitor. this may result in delayed treatment of the patient. the manufacturer advises users to observe system for any of the described symptoms. if experiencing intermittent audio or there is no audio from the piic / piic ix, while it is not connected to another audible alarm annunciation system, users should not rely exclusively on the audible alarm system for patient monitoring. as this issue does not affect video functionality, visual alarming remains operational and close observation of the piic / piic ix display should be provided. philips will replace the audio cable on affected devices. 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 7 december 2012.
Device
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Modèle / numéro de série
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Description du dispositif
Medical Device Safety Alert: Philips IntelliVue Information Center and Philips IntelliVue Information Center iX
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
DH