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Alerte Ou Avis De Sécurité sur ClinActiv and ClinActiv Plus Therapy Surface
Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Hill-Rom.
Qu'est-ce que c'est?
Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.
En savoir plus sur les données ici-
Type d'événement
Safety alert / Field Safety Notice
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ID de l'événement
MDA/2013/086
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Numéro de l'événement
CON355521
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Date
2013-12-19
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Date de publication de l'événement
2013-12-19
- Pays de l'événement
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Source de l'événement
MHRA
- URL de la source de l'événement
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Notes / Alertes
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom. -
Notes supplémentaires dans les données
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Cause
Silicone oil may leak out of the pressure sensor of the mattress and spill onto the floor. patients or carers may slip in the oil and injure themselves. the manufacturer has developed instructions on how to clean up these leaks but they were not included in the field safety notice dated 22 july 2013. in addition, the manufacturer has not received sufficient confirmation from users that they have received and acted upon this information. the mhra remains in discussion with hill-rom about its corrective actions and sensor replacements.
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Action
Ensure all staff are aware of the instructions on how to clean up any silicone oil leakage (see appendix). Ensure the sensors are: checked annually replaced at least every 3 years included in your maintenance programmes. Return the customer response form to Hill Rom.
Device
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Modèle / numéro de série
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Description du dispositif
Pressure reducing air mattresses: ClinActiv and ClinActiv Plus Therapy Surface. Manufactured by Hill-Rom. Models N02050, N02051, P02062, P02063, P02064 and P02065. All serial numbers are affected
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
MHRA