BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFESYNC ECG SYSTEM

    MDR report key: 1001563 · Received February 21, 2008

    Report

    Report Number
    3003829651-2008-00008
    Event Type
    Death
    Date Received
    February 21, 2008
    Date of Event
    December 25, 2007
    Report Date
    February 14, 2008
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE PATIENT DID NOT SURVIVE THE CARDIAC ARREST. ADDITIONAL CLARIFICATION / INVESTIGATION PERFORMED ON BEHALF OF LIFESYNC CORPORATION WITH NURSES THAT WERE ON SITE AT THE TIME OF THE INCIDENT INDICATED THAT THE LEADWEAR BROKE DURING CHEST COMPRESSIONS, THE PATIENT WAS GRAVELY ILL AT THE TIME OF THE INCIDENT, AND THE OUTCOME OF RESUSCITATION WAS NOT IMPACTED IN ANY WAY BY THE LEADWEAR BREAK. IN THIS CASE, A DEVICE FAILURE OCCURRED, BUT WAS NOT RELATED TO THE OUTCOME OF TREATMENT TO THE PATIENT. DEVICE FAILURE WAS NOT RELATED TO THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    A LIFESYNC CORPORATION SALES REPRESENTATIVE WAS RECORDING FEEDBACK OBTAINED DURING A MEETING WITH A CUSTOMER. THE CUSTOMER INDICATED TO THE LIFESYNC REPRESENTATIVE THAT THEY WERE ATTEMPTING TO RESUSCITATE A PATIENT THAT WAS IN CARDIAC ARREST, WHILE PERFORMING CPR, THE LEADWEAR BROKE. THE CUSTOMER INDICATED THAT THE BREAK IN THE LEADWEAR MADE IT DIFFICULT TO MONITOR THE PATIENT DURING THE CARDIAC ARREST. MONITOR OF THE PATIENT RESUMED WHEN DEFIBRILLATOR PADS WERE PLACED. BROKEN LEADWEAR DURING RESUSCITATION HAS THE POTENTIAL TO LEAD TO A DELAY IN TREATMENT DURING AN EMERGENCY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESYNC ECG SYSTEM WIRELESS ECG SYSTEM DRT LIFESYNC CORPORATION NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death