BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE-72 CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, DSE

    MDR report key: 3535315 · Received December 24, 2013

    Report

    Report Number
    8030647-2013-00024
    Event Type
    Malfunction
    Date Received
    December 24, 2013
    Date of Event
    November 29, 2013
    Report Date
    November 29, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ONCE SAMPLES ARE EVALUATED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE, WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6), ¿THE NURSE FOUND THE DSE TRACH CARE HAD BROKEN DURING USE. THE RESPIRATOR MACHINE WAS ALARMING, THE NURSE CHECKED THE CONNECTION BETWEEN THE RESPIRATOR AND THE TRACH CARE AND FOUND THE DSE TRACH CARE WAS ALREADY BROKEN. THE PATIENT CAN MOVE ITS LEFT HAND AND TAKE OFF THE CONNECTION BY ITSELF AS NOTED FROM PAST OCCURRENCE. THE NURSE WAS NOT AT THE BEDSIDE WHEN THE RESPIRATOR WAS ALARMING, THEREFORE NOBODY KNOWS HOW THE DSE TRACH CARE WAS BROKEN.¿ KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674609 TRACH CARE-72 CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, DSE CLOSED SUCTION TRACH CARE SYSTEM BSY KIMBERLY-CLARK HEALTH CARE M3122T711

    Patients

    Seq Age Sex Outcome Treatment
    1