BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROLON

    MDR report key: 254962 · Received December 14, 1999

    Report

    Report Number
    254962
    Event Type
    Malfunction
    Date Received
    December 14, 1999
    Date of Event
    November 4, 1999
    Report Date
    November 29, 1999
    Manufacturer
    CAROLON CO.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON 11/4/99, A CAROLON TRINITY COMPRESSION PUMP, IN USE ON PT, WAS FOUND BY NURSE TO BE SMOKING. THE PUMP WAS UNPLUGGED AND REMOVED FROM SERVICE. THE PUMP WAS EXAMINED BY CLINICAL ENGINEERING SERVICE AND IT WAS FOUND THAT THE PIN FOR THE HOT SIDE OF THE MALE POWER RECEPTACLE ON THE UNIT WAS PUSHED IN AND BURNT AND THE CASING AROUND IT WAS CRACKED. A HOLE WAS BURNT THROUGH THE REMOVABLE POWER CORD WHERE IT CONNECTED TO THE UNIT. ON 11/23/99, A GROUP OF 6 CAROLON TRINITY COMPRESSION PUMPS, WHICH WERE REPORTED AS BROKEN, WERE EXAMINED BY CLINICAL ENGINEERING BEFORE BEING SENT BACK TO THE MFR FOR REPLACEMENT UNDER THE LEASE CONTRACT. IT WAS FOUND THAT ALL 6 PUMPS ALSO HAD THE PIN PUSHED IN AND CRACKS IN THE RECEPTACLE CASING. THE REMAINING CAROLON TRINITY COMPRESSION PUMPS WERE REMOVED FROM SERVICE ASAP AFTER FINDING THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROLON COMPRESSION PUMP JOW CAROLON CO. TRINITY DVT SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other