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Alerte De Sécurité sur heartstart mrx monitor/defibrillators
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
2014-02-26
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Date de publication de l'événement
2014-02-26
- 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/defibrillators medical device manufacturer, philips healthcare, has issued a field safety notice concerning heartstart mrx monitor/defibrillator. the affected model numbers and serial numbers are as follows: model m3535a: us00100100 to us00541372 model m3536a: us00100902 to us00541375 model m3536j: us00209838 to us00332675 model m3536mc: us00500001 to us00500020 according to the manufacturer, a component of the mrx processor board may be susceptible to damage from electrostatic discharge. damage to these components can disrupt electrocardiography (ecg) and pulse oximetry (spo2) functionality leading to an inability to perform: demand mode pacing 12 lead ecg acquisition and analysis ecg monitoring via leads pulse oximetry (spo2) the presence of this condition will be displayed on the ready for use indicator as a solid red x with periodic audio chirp. a hardware upgrade will be provided to correct the issue. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. the manufacturer also provides instruction for the appropriate actions to be taken if the affected product displays a solid red ‘x’. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 february 2014.
Device
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Modèle / numéro de série
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Description du dispositif
Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
- Manufacturer
Manufacturer
- Société-mère du fabricant (2017)
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Source
DH