BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADENCE PHYSIO QC ADULT RTS

    MDR report key: 3131611 · Received May 17, 2013

    Report

    Report Number
    1219103-2013-00024
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 14, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. PRODUCT MONITORING HAS REQUESTED ADDITIONAL INFORMATION. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS THAT A SET OF DEFIBRILLATOR PADS WERE PLACED ON THE PATIENT, BUT THE MONITOR DID NOT DISPLAY ANY RHYTHM. ANOTHER MONITOR WAS ATTACHED TO THE DEFIBRILLATOR PADS AND THERE CONTINUED TO BE NO RHYTHM DISPLAYED ON THE NEW MONITOR. A SECOND SET OF DEFIBRILLATOR PADS WERE PLACED ON THE PATIENT AND A RHYTHM WAS DETECTED. THERE WERE NO PROBLEMS WITH THE MONITOR; IT WAS CHECKED BY CLINICAL ENGINEERING. THE PATIENT DID NOT REQUIRE DEFIBRILLATION BUT THE FIRST SET OF ELECTRODES DID NOT DETECT RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220193 CADENCE PHYSIO QC ADULT RTS DEFIBRILLATION ELECTRODES MLN COVIDIEN 22550R 301844X

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR