Events

Alerte De Sécurité sur micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Pace Medical.

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
    2012-07-06
  • Date de publication de l'événement
    2012-07-06
  • 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_20120706.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: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580 it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580. the manufacturer has had isolated reports of intermittent sensing issues with the affected product. under some circumstances, the affected device would fail to resume nominal sense operation once the programmed rate was lowered or became lower than the patients intrinsic rate. this was determined to be associated with depolarization of the regions surrounding the patient leads. with higher lead impedances the region surrounding the patient lead would take longer than expected to depolarize. this resulted in an extended offset period, which interfered with the device’s differential sense input amplifier. decreasing the device’s input impedance to 10k solved the depolarization effect allowing nominal sense operation with maximal rates and programmed outputs. a simple hardware change eliminates the potential for this occurrence. the manufacturer advised users that: they should return the affected product for complimentary upgrade. they may use the device while scheduling product return; however it is recommended that patients are monitored while the device is in use and that the device is not used with patients with “heart wires” until the modification has been made to the device. if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 july 2012.

Device

micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580
  • Manufacturer
    Pace Medical

Manufacturer

Pace Medical