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.
Heart sync multi-function defibrillation electrodes will not connect with philips fr3 or frx aed units. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the fr3, however, does not require pre-connection and the user may not discover the incompatibility issue until the.
조치
The firm, HeartSync, sent an "Voluntary Field Safety Alert for Heart Sync Multi-function Defibrillator Electrodes" notice dated 11/11/2014 to customers via email notifying them of the incompatibility with the Philips FR3 and FRX AEDs and requesting response to the notice. On 12/1/2014 (dated 11/26/2014) Heart Sync issued a Voluntary Device Correction via Press Release. The Press Release included a description of the reason for the recall, affected product, and instruction that the Philips FR3 and FRx AED units should only be used with electrodes specified in the (Philips) equipment manuals.
For further information or to report a problem, please contact Heart Sync at 734-213-5530, 24 hours a day, 7 days a week, ,or email at Jahana@heartsync.net.
Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.
제품 설명
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.