Events

Safety Alert for SenSit Chair

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Protac A/S.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-07-02
  • Event Date Posted
    2013-07-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130702.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: protac sensit chair the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning the following sensit chair manufactured by protac a/s: product no.: 600-601 standard model product no.: 600-701 high model product no.: 600-601-3500 standard model product no.: 600-701-3500 high model protac has heard that an over-excited child in the uk managed to get his head caught in one of the carrying straps on the protac sensit chair. as the strap sat around the child’s throat, he was unable to free himself. however, the staff managed to cut the handle so that fortunately nothing happened to the child. to minimize events of this type from recurring, the manufacturer has implemented the following measures: protac is sending a safety notice together with a warning (please note! take care to ensure the user’s head does not get caught in the carry straps.) to institutions and private customers who have purchased or who are using protac sensit chairs to draw their attention to this potential risk. protac is also sending the safety notice with the warning to all foreign dealers in europe and australia, who must in turn inform their customers, institutions and private customers of this potential risk. protac has redesigned the carrying straps on its protac sensit chair so that the new chair has new and safe straps. protac advises the customers to assess the safety risk and implement any precautionary measures whenever necessary. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con286973 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 july 2013.

Device

SenSit Chair
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Protac SenSit Chair
  • Manufacturer
    Protac A/S

Manufacturer

Protac A/S