Events

Alerte De Sécurité sur m1783a and m5526a 12 pin sync cables

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
    2014-12-12
  • Date de publication de l'événement
    2014-12-12
  • 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_20141212.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 m1783a and m5526a 12 pin sync cables the australian therapeutic goods administration (tga), has issued a medical device safety alert concerning its heartstart xl (m1783a and m5526a) 12 pin sync cables, manufactured by philips medical systems. according to the tga, the following problems were found during internal testing:-if electrical fast transits (eft) noise is injected into the monitor/defibrillator via ac mains power, and the monitor/defibrillator is connected to and receiving ecg signals from an auxiliary bedside monitor with an m1783a/m5526a 12 pin sync cable (8/24 feet) via the monitor’s ecg out port, then:- issue 1: when using a sync cable with the heartstart mrx or heartstart xl, eft noise can be mistaken as an r-wave. if this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to eft noise instead of the patient’s actual r-wave. issue 2: when using a sync cable with the heartstart xl+, eft noise can disable ecg monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. a power cycle is required to resume ecg monitoring, however, fixed mode pacing is not impacted by this issue. the manufacturer will contact affected customers to arrange for replacement of new sync cable. for details, please refer to the following link: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2014-rn-01291-1 according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2014.

Device

m1783a and m5526a 12 pin sync cables
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Medical Systems M1783A and M5526A 12 pin Sync Cables
  • Manufacturer
    Philips Medical Systems

Manufacturer

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