BEUDAMED
    FDA Adverse Event Summary report: N

    SKYTRON

    MDR report key: 1981783 · Received January 28, 2011

    Report

    Report Number
    1825014-2011-00001
    Date Received
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MIZUHO
    Product Code
    FQO
    Report Source
    Distributor report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN RESPONSE TO (B)(6) HOSPITAL IN (B)(6) RECEIVED ON (B)(6) 2011. SKYTRON'S DISTRIBUTOR IN THE (B)(6) AREA, (B)(6), WENT TO THE FACILITY TO EXAMINE THE TABLE. PRIOR TO THE PT'S PROCEDURE, THE FACILITY REVERSED THE HEAD SECTION AND THE LEG SECTION MAKING THE TABLE'S WEIGHT CAPACITY OF 1000 POUNDS BECOME A WEIGHT CAPACITY OF 500 POUNDS. THE PT WEIGHED (B)(6) POUNDS PER THE FACILITY. (B)(6) WAS TOLD BY THE FACILITY THAT THE TABLE WAS REPAIRED BY A FACILITY TECHNICIAN; HOWEVER, THEY DO NOT KNOW WHO IN PARTICULAR THE TABLE WAS REPAIRED BY. THEREFORE NEITHER SKYTRON NOR (B)(6) HAS BEEN INFORMED OF THE DAMAGE OR REPAIR METHOD. IT IS SKYTRON'S POLICY THAT THE FACILITY BIOTECHS ATTEND OUR SERVICE SCHOOL TO BE CERTIFIED FOR 3 YEARS PRIOR TO REPAIRING SKYTRON'S SURGICAL TABLES. TO DATE, SKYTRON DOES NOT HAVE RECORD OF A TECHNICIAN FROM ( B)(6) HOSPITAL IN (B)(6) ATTENDING SERVICE SCHOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE FQO MIZUHO 6700B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *