Events

Alerte De Sécurité sur HeartStart XL+ Defibrillator/Monitor

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 Medical Systems.

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
    2015-07-06
  • Date de publication de l'événement
    2015-07-06
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150706.html
  • 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 medical systems heartstart xl+ defibrillator/monitor the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning philips heartstart xl+ defibrillator/monitor manufactured by philips medical systems. the affected heartstart xl+ defibrillator/monitor units include serial numbers within the following ranges: uso1100100 to usd1101095 us11201096 to usd1203968 us11303969 to usd1309471 us11409472 to us61414022 the manufacturer has identified the following xl+ software and hardware issues:- software issues: the xl+ may fail to complete the power on sequence and continuously reboot. the xl+ may either fail to power up or may shut down unexpectedly. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. the xl+ may fail to generate verbal prompts in automated external defibrillator (aed) mode. hardware issues: the xl+ may have been manufactured with a speaker that may fail. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. the xl+ exceeds the allowable radiated emissions level for class b cispr11. the xl+ ecg signal from leads could be lost and unrecoverable. the xl+ spo2 signal may lose communication and cause the device to reboot. the xl+ battery detection system may be disrupted and cause a false low battery alarm according to the alert, the manufacturer will contact customers with affected devices to arrange for installation of the software and hardware upgrades. in the interim, the manufacturer advises users that they can continue to use their xl+ prior to receiving the software and hardware upgrades, provided they should identify a readily available backup defibrillator to use in the event the affected heartstart xl+ exhibits any of these issues. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00588-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 july 2015.

Device

HeartStart XL+ Defibrillator/Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [6 Jul 2015] Philips Medical Systems HeartStart XL+ Defibrillator/Monitor
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH