The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Articles - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
Alerte De Sécurité sur DigitalDiagnost Patient support for stitching
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
2014-04-04
-
Date de publication de l'événement
2014-04-04
- Pays de l'événement
-
Source de l'événement
DH
- URL de la source de l'événement
-
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 digitaldiagnost patient support for stitching medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its digitaldiagnost patient support for stitching. according to the manufacturer, the footboard of patient support for stitching can be fixed in upper position. when the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. if it falls down, it may hurt the operator’s or patient’s foot (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the board up). the following factors are needed for the situation to occur: hook not correctly adjusted operator does not recognize that the hook does not click into place patient support is moved (wheeled around) hook does not hold foot in hazard area” the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm. the affected users are advised to always check the right position of the hook and that the hook is locked. according to the manufacturer, 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 04 april 2014.
Device
-
Modèle / numéro de série
-
Description du dispositif
Medical Device Safety Alert: Philips DigitalDiagnost Patient support for stitching
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
-
Source
DH