Events

Alerte De Sécurité sur Quick connect scales used with Maxi Sky 2 ceiling lifts

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
    2018-02-23
  • Date de publication de l'événement
    2018-02-23
  • 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_20180223c.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 quick connect scales used with maxi sky 2 ceiling lifts medical device manufacturer, arjohuntleigh, has issued a medical device safety alert concerning its quick connect scales used with maxi sky 2 ceiling lifts the affected products are as follows: - product codes: a) 700-19485; b) 700-19490 serial numbers: a) from 300146551 up to 300220716; b) from 300142013 up to 300219867 manufactured between june 2016 and november 2017. the manufacturer has received a limited number of complaints where it was mentioned there was a disconnection occurrence of the spreader bar from the quick connect scale. according to the manufacturer, the hazard could be replicated under a specific sequence of events. if a spreader bar detaches from the quick connect attachment of the scale, a patient can fall and may lead to a potential risk of injury. the manufacturer shall arrange local service technician to visit the facilities to carry out the upgrade of the scales. the affected customers are requested 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 facility are available to be corrected during service technician visit. the device may stay in use until the upgrade will be performed, on the condition that the following instructions are carefully followed: before initiating the patient transfer, once the patient is installed in the sling and the weight is gradually taken up, always check that the scale quick connect lower attachment is aligned with the spreader bar quick connect. if not, do not proceed with the patient transfer, lower the patient, remove completely the patient weight on the scale and then reinstall adequately the spreader bar attachment. 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 february 2018.

Device

Quick connect scales used with Maxi Sky 2 ceiling lifts
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ArjoHuntleigh Quick connect scales used with Maxi Sky 2 ceiling lifts
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh