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Alerte De Sécurité sur EasyDiagnost (70642, 70643, 706030, 706031, and 706032)
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
2012-08-06
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Date de publication de l'événement
2012-08-06
- 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 easydiagnost medical device manufacturer, philips healthcare, has initiated a field safety corrective action for philips easydiagnost (70642, 70643, 706030, 706031, and 706032). only units that have had the inclination switch replaced during service are affected. according to the manufacturer, an inclination switch in the stand may have been mounted incorrectly during system service. there is a potential that a significant compression force could be exerted on a patient if, due to a combination of software and hardware errors, the inclination switch is not activated and the tilting movement is not immediately stopped. this severe squeezing has the potential to result in serious harm or injury. however, there is a very low probability that this combination of errors would occur. the manufacturer advised users to refer to the ifu for actions taken in preventing unintended compression by inserting the "compression stop" in the highest position. a field service engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly s/he will reinstall it properly. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.
Device
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Modèle / numéro de série
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Description du dispositif
Medical Device Safety Alert: Philips EasyDiagnost
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
DH