Events

Recall of HeartSine Samaritan(R) 300/300P PAD devices

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heartsine Technologies, Limited.

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
    63139
  • Event Risk Class
    Class 1
  • Event Number
    Z-0124-2013
  • Event Initiated Date
    2012-09-13
  • Event Date Posted
    2012-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112662
  • 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 - Product Code MKJ
  • Reason
    Certain samaritan 300/300p pad devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an sca event if needed: issue 1 (on/off issue): the device may turn itself on and off without input from the user. when this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit.
  • Action
    HeartSine sent an Urgent: Medical Device Recall dated September 2012 to all affected customers. The letter identifed the affected product, problem and actions to be taken. A response form was included with the letter to be completed by customers and returned to the recalling firm's representative. In addition, HeartSine is providing a software upgrade to bring all users up to a more recent version of the software. For questions call 1-877-877-0147 or your service representative.The company issued an additional press release on September 13, 2013 in a further attempt to reach out to end customers that had not yet responded to the companys efforts.

Device

HeartSine Samaritan(R) 300/300P PAD devices
  • Model / Serial
    Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Product Description
    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 || Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: || Unconsciousness || Not breathing || Without circulation
  • Manufacturer
    Heartsine Technologies, Limited

Manufacturer

Heartsine Technologies, Limited
  • Manufacturer Address
    Heartsine Technologies, Limited, 203 Airport Road West, Belfast United Kingdom
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA