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Alerte De Sécurité sur HeartStart MRx monitor/defibrillator
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
2012-08-08
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Date de publication de l'événement
2012-08-07
- 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 heartstart mrx monitor/defibrillator health canada posted a medical device safety alert concerning heartstart mrx monitor/defibrillator (model no.: m3535a, m3536a), manufactured by philips medical systems. according to the report, the manufacturer has become aware that affected devices may exhibit the following behaviors: in aed mode the device experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to analyze the waveform. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy in addition the devive may provide erroneous alarms (e.G. pvc/min high, vtach, asystole) or indicate an asystolic rhythm when paddles are not in patient contact. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback. for details, please refer to the health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 august 2012.
Device
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Modèle / numéro de série
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Description du dispositif
Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
DH