BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 6744812 · Received July 26, 2017

    Report

    Report Number
    1043572-2017-00051
    Event Type
    Malfunction
    Date Received
    July 26, 2017
    Date of Event
    November 30, 2012
    Report Date
    July 26, 2017
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDWATCH REPORT STATES THE REPORTED EVENT OCCURRED IN 2012 HOWEVER, STERIS WAS NOT MADE AWARE OF THE REPORTED EVENT UNTIL THE MEDWATCH REPORT WAS RECEIVED ON JUNE 27, 2017. A REVIEW OF STERIS SERVICE RECORDS FOR THE SUBJECT SURGICAL TABLE INDICATES THAT STERIS HAS NOT PERFORMED SERVICE OR MAINTENANCE ON THE TABLE SINCE 2010. THE SURGICAL TABLE WAS INSTALLED IN 2005 AND IS SERVICED AND MAINTAINED BY THE USER FACILITY. A STERIS SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY FOLLOWING THE RECEIPT OF THE MEDWATCH REPORT TO INSPECT THE CMAX SURGICAL TABLE. THE STERIS SERVICE TECHNICIAN INSPECTED THE SURGICAL TABLE AND FOUND IT TO BE OPERATING PROPERLY WITH NO ISSUES NOTED. THE TECHNICIAN CONFIRMED THAT THE HEAD SECTION OF THE SURGICAL TABLE ALONG WITH OTHER ATTACHMENTS WERE PROPERLY SECURED. THE SURGICAL TABLE WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. DURING THE TECHNICIANS ONSITE VISIT HE SPOKE WITH THE USER FACILITY'S BIOMED AND OR DIRECTOR REGARDING THE IMPORTANCE OF ENSURING ALL ATTACHMENTS ARE PROPERLY SECURED TO THE SURGICAL TABLE PRIOR TO PATIENT PROCEDURES. -

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THE TABLE'S HEAD SECTION BROKE AND FELL. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523982 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1