BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKYTRON

    MDR report key: 921716 · Received September 20, 2007

    Report

    Report Number
    1825014-2007-00013
    Event Type
    Other
    Date Received
    September 20, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 20, 2007
    Manufacturer
    MIZUHO MEDICAL CO., LTD
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SKYTRON WAS MADE AWARE OF THIS INCIDENT IN 2007, HOWEVER, WE WERE TOLD BY THE HOSPITAL'S BIO-TECHNICIAN THAT THERE WERE NO INJURIES. WE CONTACTED OUR DISTRIBUTOR IN THE AREA, AND ASSOCIATES TO GO TO THE HOSPITAL AND EXAMINE THE TABLE. THE HOSPITAL WAS ADVISED BY SKYTRON TO TAKE THE TABLE OUT OF SERVICE BUT THEY REFUSED. THEY MADE THE DECISION TO USE THE TABLE WITHOUT REPAIR REGARDLESS OF THE RISK. UNK SERIAL NUMBER AT THIS TIME. WE WERE INFORMED ON THE FOLLOWING MONTH, THAT THERE WAS AN INJURY TO A PATIENT AND ARE AWAITING THE INFORMATION. THE TABLE HAS BEEN REPAIRED AND CONTINUES TO BE IN SERVICE. WE WILL SEND A FOLLOW UP AS SOON AS THE DETAIL OF THE INJURY IS KNOWN.

    Description of Event or Problem · 1

    HOSPITAL CLAIMS SKYTRON'S 6500 SURGICAL TABLE WENT INTO TRENDELENBURG AND TILT LEFT ON IT'S OWN. HOSPITAL NOW CLAIMS AN INJURY TO PATIENTS BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE BWN MIZUHO MEDICAL CO., LTD 6500NB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR