Events

Recall of SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR(AED)- MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESCUE 7 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
    102713
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Devices within these serial number ranges may be affected by one of both of these 2 identified. issue one: devices may intermittently or sometimes repeatedly switch themselves on and remain on for 10minutes which could eventually cause premature depletion of battery capacity. should this condition not be detected the battery may become depleted below a level where it could power the device to safely deliver therapy if required. issue two: the battery management software in affected devices may mis-interpret changes in voltage which occur during the normal operation of the device as indications of a low battery capacity. this can trigger an unnecessary low battery warning which if it occurs during an rescue event may cause the device to switch off and/or may delay the delivery of shock therapy.

Device

SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR(AED)- MAIN UNIT
  • Model / Serial
    Model Catalog: SAM-300 (Lot serial: 10C00200000 - 10C00210106); Model Catalog: SAM-300 (Lot serial: 040000501 - 0700032917); Model Catalog: SAM-300 (Lot serial: 08A00035000 - 10A0070753); Model Catalog: SAM300P (Lot serial: 040000501 - 0700032917); Model Catalog: SAM300P (Lot serial: 10C00200000 - 10C00210106); Model Catalog: SAM300P (Lot serial: 08A00035000 - 10A0070753)
  • Product Description
    samaritan PAD SAM 300/300P
  • Manufacturer
    RESCUE 7 INC.

Manufacturer

RESCUE 7 INC.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Rescue 7 Inc
  • Source
    HC