Events

Safety Alert Or Field Safety Notices for Kimba Spring paediatric buggies

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Otto Bock.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/096
  • Event Number
    CON2033329
  • Date
    2007-12-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2033329
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of injury to the occupant due to frame failure and the seat suddenly tilting fully forwards or backwards. the mhra has received reports of failures of the seat tilt actuator frame mounting on kimba spring paediatric buggies manufactured by otto bock (see appendix figures a – d). the failure may lead to the seating system becoming insecure allowing it to fully tilt forwards or backwards without warning. a head injury has occurred as a result of this happening. otto bock has carried out extensive tests but has been unable to reproduce these failures when the buggy is used in accordance with the ifu. it is possible that the failures were caused by overloading the frame. in may 2007, otto bock introduced a modification kit for the kimba spring. a bracket is to be fitted that will limit the range of tilt and which reduces the risk to users in the event of a frame failure. with the seat unit removed, fitting of the bracket takes approximately five minutes. otto bock has also updated the ifu. copies of the latest version of the ifu, catalogue number: 647g116-04.03\3, and the transportation document, catalogue number: 646d158-600-05.07\7, can be obtained from otto bock at the address given below. users, carers and transport providers should ensure that the buggy is used as stated in the ifu at all times. if it is used in transport, a tie-down system and occupant restraint should be employed in accordance with the ifu from otto bock.
  • Action
    Trace all Kimba Spring paediatric buggies, in use or held in storage, which were supplied between April 2003 and April 2007 and inspect the seat tilt actuator frame mounting and surrounding area (see photographs in appendix - in pdf only). Withdraw from service all those buggies showing signs of damage or cracks and contact Otto Bock for a replacement frame. If no damage or cracks are found on the frame contact Otto Bock for the modification bracket and fitting instructions. Make arrangements to fit the new bracket. Ensure that all users have the latest version of the Kimba Spring instructions for use (IFU), including the separate document detailing how it may be used as a seat in transport.

Device

Kimba Spring paediatric buggies
  • Model / Serial
  • Product Description
    Kimba Spring paediatric buggies manufactured by Otto Bock. All Kimba Spring paediatric buggies with the following part number(s): HR32901000 (size 1 rigid), HR32911000 (size 1 swivelled) and HR32931000 (size 2 swivelled) supplied between April 2003 and April 2007. Size 1 is intended for children aged approximately 1 to 6 years; size 2 for children aged 4 to 10 years.
  • Manufacturer
    Otto Bock

Manufacturer

Otto Bock