Events

Safety Alert Or Field Safety Notices for SCHILLER FRED AED: Defibrillation Electrodes

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 Schiller.

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/2012/043
  • Event Number
    CON172294
  • Date
    2012-07-11
  • Event Date Posted
    2012-07-11
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172294?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
    Premature drying up of electrodes due to a manufacturing quality problem. this may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient. users have reported that these electrodes partially dry up before their expiry date, possibly due to variations in the manufacturing process. if the electrodes partially dry up, there is a risk that they will not be detected by the defibrillator, as their impedance is too high.
  • Action
    See manufacturer’s Field Safety Notice issued May 2012 by Amazon Medical Limited. MDA/2012/042 and MDA/2012/043 refer to this Field Safety Notice. Check inventory and identify affected electrodes. If affected, immediately contact Amazon Medical Limited for replacement electrodes. Return the fax back confirmation form in the FSN to Amazon Medical Limited.

Device

SCHILLER FRED AED: Defibrillation Electrodes
  • Model / Serial
  • Product Description
    Schiller electrodes: silver packet, manufactured by Nessler Medizintechnik. All (Paediatric and Adult) devices are affected. Devices are distributed by Amazon Medical Ltd. The electrodes (example, right) are supplied with the FRED defibrillators or can be acquired as an accessory. All those electrodes produced before January 2011 are affected. SCHILLER FRED AED: Defibrillation Electrodes - Nessler Medizintechnik Product Article number FRED defibrillation electrodes Adult REF W1410241 FRED defibrillation electrodes Child Same packet – labelled Child REF W1410262 Schiller Fred easyport, APLC1 & APLC2 Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easyport defibrillation electrodes - Adult Same size packet as 2.155057 REF 2.155056 FRED easyport defibrillation electrodes - Child REF 2.155057 APLC1 & APLC2 defibrillation electrodes Adult REF 0‐21‐0024 Schiller Fred easy Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easy defibrillation electrodes REF 0-21-0003 FRED easy REF 0-21-0020 FRED easy REF 0-21-0000 FRED easy REF 0-21-0021 The Schiller electrodes are used with the following defibrillators/monitors manufactured by Schiller. Products FRED easy Basic FRED easy ECG on-screen FRED easy Manual FRED AED FRED easyport APLC1 FRED easyport APLC2 AT101 easy Argus Pro Lifecare 1 Argus Pro Lifecare 2
  • Manufacturer
    Schiller

Manufacturer

Schiller