BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PUMP

    MDR report key: 2924056 · Received December 13, 2012

    Report

    Report Number
    1717344-2012-01239
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN LP
    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 PUMP HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FIRST ABLATION WAS COMPLETED WITHOUT ANY PROBLEM. HOWEVER, UPON TURNING THE PUMP ON AFTER INSERTION OF THE NEEDLE, THE PUMP WOULD NOT WORK AT ALL. AFTER TURNING THE PUMP ON AND OFF AGAIN, THE PROBLEM CONTINUED. THE PROCEDURE WAS SUSPENDED WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION PUMP RF ABLATION ACCESSORY GEI COVIDIEN LP LO50123

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR