Events

Alerte De Sécurité sur Akron Tilt Table

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

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
    2018-05-23
  • Date de publication de l'événement
    2018-05-23
  • 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_20180523a.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: arjohuntleigh akron tilt table medical device manufacturer, arjohuntleigh, has issued a medical device safety alert concerning its akron tilt table [model number: a8652, a8652t; serial number: between p0167499 and p0418644]. the manufacturer received a customer complaint related with akron tilt table middle section frame breakage in its post-market surveillance monitoring. the investigation showed that one of critical welds in the part was missing. there was no injury related to this incident. according to the manufacturer, the issue is related with potential hazard for patients and if the affected device will be used it can lead to collapse during movement to the vertical position. in the worst case, scenario user can fall down with the upholstery (if not protected with belts). the manufacturer will arrange a service technician to visit the facilities to carry out welds presence verification and the frame replacement if a missing weld/missing welds would be detected. it is not recommended to use the couch until action would be taken by the manufacturer. the affected customers are instructed to ensure that all caregivers and users of the affected devices are made aware of the field safety notice and all listed devices at their facilities are available to be corrected during service technician visit. 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 23 may 2018.

Device

Akron Tilt Table
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ArjoHuntleigh Akron Tilt Table
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh