BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANOP INFECTION CONTROL SYSTEM

    MDR report key: 10368181 · Received August 5, 2020

    Report

    Report Number
    1043582-2020-00007
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    ECOLAB/MICROTEK MEDICAL
    Product Code
    KME
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE SHEETS DID NOT HAVE ENOUGH GRIP TO HOLD THE PATIENTS POSITION AND THREE PATIENTS HAD SLIPPED ON THE TABLE WHILE USING THE TABLE SHEET FROM THE CONVENIENCE KIT. ONE PATIENT WAS PLACED IN A DEEP TRENDELENBURG AND THE PATIENT WAS OBSERVED SLIDING OFF THE TABLE. THE TABLE SHEETS WERE USED AS A POSITIONER AND OFF LABEL USE WAS CONDUCTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831767 CLEANOP INFECTION CONTROL SYSTEM TABLE SHEET KME ECOLAB/MICROTEK MEDICAL SMHF-06D

    Patients

    Seq Age Sex Outcome Treatment
    1