BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANOP INFECTION CONTROL SYSTEM

    MDR report key: 10449103 · Received August 25, 2020

    Report

    Report Number
    1043582-2020-00008
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ECOLAB/MICROTEK MEDICAL IN.
    Product Code
    KME
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SLID OFF OF THE OPERATING ROOM TABLE WHILE IN TRENDELENBURG POSITION DURING ROBOTIC CASE. PATIENT WAS NOT INITIALLY STRAPPED/TAPED TO TABLE BUT WAS EVENTUALLY TAPED ON SHOULDERS & TORSO. THERE WERE NO PATIENT OR STAFF INJURIES AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913730 CLEANOP INFECTION CONTROL SYSTEM TABLE SHEET KME ECOLAB/MICROTEK MEDICAL IN. SHMC-06

    Patients

    Seq Age Sex Outcome Treatment
    1