Events

Field Safety Notices about Stryker Model 6100 M1 Ambulance Cot

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Stryker Medical.

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
    Field Safety Notice
  • Event Number
    SN2010(012)
  • Date
    2010-09-30
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/stryker-model-6100-m1-ambulance-cot&id=6d8af825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    Stryker has become aware that the head end slide tube, bushings and head end release rod of the model 6100 m1 ambulance cot can break during use, potentially resulting in the head end of the cot collapsing.
  • Action
    As there are no sales records, the IMB are requesting that healthcare workers contact Stryker UK if they are aware that this device has been distributed in Ireland.  If affected devices are located at your facility and the unit does not operate properly, remove the unit from service and contact Stryker UK to arrange for a device retrofit / upgrade. The attached field safety notice issued by Stryker provides further information on this issue.

Device

Stryker Model 6100 M1 Ambulance Cot
  • Model / Serial
  • Product Description
    Stryker Model 6100 M1 Ambulance Cot
  • Manufacturer
    Stryker Medical

Manufacturer

Stryker Medical
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HPRA