Events

Recall of Hard shell carry case for the LIFEPAK 500 AED.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Emergency Response Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32642
  • Event Risk Class
    Class 2
  • Event Number
    Z-0004-06
  • Event Initiated Date
    2005-07-12
  • Event Date Posted
    2005-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40482
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Some hard shell carry case for lifepak 500 and lifepak cr plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
  • Action
    On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.

Device

Hard shell carry case for the LIFEPAK 500 AED.
  • Model / Serial
    Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Cases were distributed nationwide and internationally.
  • Product Description
    Hard shell carry case for the LIFEPAK 500 AED.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Manufacturer Address
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA