BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE PHYSIO QC ADULT RTS

    MDR report key: 3071168 · Received April 8, 2013

    Report

    Report Number
    1219103-2013-00015
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THAT DURING A CARDIOVERSION THEY LOST THE SIGNAL WHILE SETTING UP THE CASE. THEY HAD TO THE CHANGE PADS TO GET ONE WITH A TRACING. THE CUSTOMER REPORTS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143008 CADENCE PHYSIO QC ADULT RTS DEFIBRILLATION ELECTRODES MLN COVIDIEN 22550R 305320X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK