BEUDAMED
    FDA Adverse Event Summary report: N

    ORTHOVISION TABLE

    MDR report key: 2883670 · Received December 21, 2012

    Report

    Report Number
    1043572-2012-00102
    Date Received
    December 21, 2012
    Date of Event
    July 5, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    JEB
    PMA / PMN Number
    K905816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SURGICAL TABLE AND FOUND IT TO BE OPERATING TO SPECIFICATIONS. THE STERIS ACCOUNT MANAGER VISITED THE CUSTOMER AND PROVIDED THEM WITH A REPLACEMENT COPY OF THE ORTHOVISION TABLES SETUP GUIDE AND REVIEWED WITH THEM THE PATIENT RESTRAINT'S THAT ARE AVAILABLE FOR USE WITH THIS TABLE. THE OPERATOR MANUAL FOR THE ORTHOVISION TABLE ALSO WARNS THAT HEALTHCARE PROFESSIONALS MUST ENSURE THE PATIENT IS SECURED TO THE TABLE IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICES (PG. 1-2). STERIS PROVIDES SUGGESTED GUIDELINES, HOWEVER, THE GUIDELINES DO NOT REPLACE GOOD MEDICAL PRACTICES AND COMMON PATIENT POSITIONING TECHNIQUES USED CLINICALLY.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOVISION TABLE ORTHOVISION TABLE JEB STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1