BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PUMP

    MDR report key: 3063378 · Received March 28, 2013

    Report

    Report Number
    1717344-2013-00230
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED, OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IMMEDIATELY AFTER THE ABLATION STARTED, THE PUMP SYSTEM STOPPED. THE CABLE WAS CHANGED, BUT THE SAME ISSUE OCCURRED AGAIN. THE CUSTOMER CONFIRMED A FUSE WAS BLOWN. THEY REPLACED THE FUSE WITH SIMILAR SORT OF FUSE BUT IT DID NOT CORRECT THE PROBLEM. THE CASE WAS SUSPENDED WITHOUT ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128929 PERFUSION PUMP RF ABLATION PERFUSION PUMP GEI COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CTRF100 ABLATION GENERATOR: S/N (B)(4)| ACT1520 ELECTRODE: L/N UNK