Events

Field Safety Notices about Zoll AED Plus Defibrillator

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

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
    SN2009(13) Updated Version
  • Date
    2011-05-23
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zoll-aed-plus-defibrillator&id=6e86f825-9782-6eee-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
    The zoll aed plus defibrillator may not deliver therapy.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of this  issue.  2. Determine if you have purchased the affected serial numbers of this product,  AED Plus devices with serial numbers below X_ _ _200000.  3. If you have an affected device confirm that the recommended actions have been completed:  Ensure that the date when the batteries were installed in your device has been checked.  a. If batteries were installed more than three (3) years ago, replace the batteries  as soon as possible and add the label provided by Zoll showing the next  scheduled replacement date. Read and add the addendum incorporating this  information to the administrator’s guide that was provided by Zoll.  b. If batteries are not more than three (3) years old, add the label provided by  Zoll completed with the next scheduled replacement date. Read and add the  addendum, provided by Zoll, incorporating this information to the  administrator’s guide.

Device

Zoll AED Plus Defibrillator

Manufacturer

Zoll Medical Corporation