BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION

    MDR report key: 3524853 · Received December 18, 2013

    Report

    Report Number
    3015876-2013-01413
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 21, 2013
    Report Date
    November 21, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K895379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ADVISED THAT THE DEVICE TESTED OK WITH A DIFFERENT SET OF INTERNAL PADDLES AND THAT THE DEVICE WAS PLACED BACK INTO SERVICE FOR USE. THE CUSTOMER DISPOSED OF THE DEFECTIVE INTERNAL PADDLES AND PURCHASED A REPLACEMENT SET. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PROCEDURE ON A DOG, THEIR INTERNAL PADDLE ASSEMBLY SET WAS NOT DETECTED BY THE DEVICE. AS A RESULT, THEY WERE UNABLE TO DEFIBRILLATE THE DOG. THE END USER OBTAINED A BACKUP INTERNAL PADDLE ASSEMBLY AND WAS ABLE TO SUCCESSFULLY TREAT THE DOG. THERE WERE NO ADVERSE EFFECTS TO THE DOG AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662076 HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1