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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: m3535a: us00100104 - us00572207 m3536a: us00100902 - us00543688 m3536j: us00209838 - us0332675 m3536m: us00500002 - us00500009 m3536mc: us00500002 - us00500028 when used in hospital transport and pre-hospital environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear could also cause the affected product to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers. the manufacturer will arrange inspection of the affected units and install a stabilizing collar if necessary. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. 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