Events

Safety Alert Or Field Safety Notices for LIFEPAK 20/20e defibrillator/monitor

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 Medtronic/Physio-Control.

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/2010/070
  • Event Number
    CON093820
  • Date
    2010-09-09
  • Event Date Posted
    2010-09-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON093820?tabName=allTabs
  • 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
    Due to component failures, which affect ac (mains) and/or dc (battery) operating power, there is a risk that the defibrillator will not deliver therapy.The corrective action programme initiated by the manufacturer will take approximately two years to complete.Problem 1: no dc (battery) operating powercurrent leakage can prevent operation when using dc battery power.  failure of dc power can result in an inability to deliver defibrillation therapy, if no ac power is available. the global failure rate is 0.9% to date.Problem 2: no ac (mains) operating powera component failure prevents ac power operation and prevents battery charging capability. failure of ac power can result in an inability to deliver defibrillation therapy if dc power is depleted.The global failure rate is 0.7% to date.Solutionaffected devices may have problem 1, or problem 2, or both problems. the following phased corrective actions to replace the power supply board have been initiated: phase 1 dc power – identifies devices at a higher risk that accounts for 92% of all dc power failures. the manufacturer expects to complete this phase in 9 to 12 months. phase 2 ac power – identifies the remaining lower risk devices that will be updated upon completion of phase 1. the manufacturer expects phase 2 to take an additional 9-12 months to complete.
  • Action
    1. Assess the need for a back-up or alternative device whilst awaiting corrective action.2. All users should ensure that: they are aware of manufacturer’s Field Safety Notice. the manufacturer’s recommended daily inspection and testing as per the operator’s checklist are performed. where possible, devices are connected to AC mains power and the DC battery kept continuously on charge. 3. The manufacturer has contacted all affected customers. However, if you wish to check if your device is affected, refer to the Field Safety Notice. Be aware of the two year timeline for completion of the corrective action. Assess the need for a back-up or alternative device during this period. If your device exhibits either or both problems, report the failure of the device to the manufacturer and to the MHRA. Arrange for repair of the device with the manufacturer.

Device

LIFEPAK 20/20e defibrillator/monitor
  • Model / Serial
  • Product Description
    LIFEPAK 20/20e defibrillator/monitor. Specific serial numbers are affected. This is an acute cardiac care device used in clinical and hospital settings. It has a dual power supply system and is designed to operate on AC (mains) power or DC (battery) power. Devices with specific serial numbers, manufactured from 31 July 2002 to 9 February 2009 inclusive, are affected. See the manufacturer’s Field Safety Notice for a list of the relevant serial numbers.
  • Manufacturer
    Medtronic/Physio-Control

Manufacturer

Medtronic/Physio-Control
  • Source
    MHRA