BEUDAMED
    FDA Adverse Event Summary report: N

    SHAMPAINE 4900B

    MDR report key: 5908352 · Received August 26, 2016

    Report

    Report Number
    1043572-2016-00072
    Date Received
    August 26, 2016
    Date of Event
    June 24, 2016
    Report Date
    August 26, 2016
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MEDWATCH INDICATES THAT THE SURGICAL TABLE IN QUESTION IS NOT A STERIS PRODUCT; STERIS CORPORATION HAS NEVER MANUFACTURED A MODEL 4900B SURGICAL TABLE. ADDITIONALLY, THE SERIAL NUMBER, (B)(4), DOES NOT MATCH THE STERIS SERIAL NUMBER CONVENTION USED BY STERIS MONTGOMERY. STERIS PERSONNEL MADE SEVERAL ATTEMPTS TO CONTACT THE USER FACILITY REGARDING THE REPORTED EVENT IN AN ATTEMPT TO IDENTIFY WHO THE MANUFACTURER OF THE SURGICAL TABLE IS; HOWEVER, OUR MESSAGES HAVE NOT BEEN RETURNED. A COPY OF THE ORIGINAL MEDWATCH ALONG WITH A COVER LETTER FROM STERIS EXPLAINING THAT WE ARE NOT THE MANUFACTURER OF THE DEVICE IN QUESTION WILL BE FORWARDED TO THE MEDICAL DEVICE REPORTING DIVISION OF THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH. SHOULD ADDITIONAL INFORMATION BE RECEIVED INDICATING A STERIS MANUFACTURED DEVICE WAS INVOLVED IN THE REPORTED EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH #(B)(4). THE USER FACILITY REPORTED THAT A SHAMPAINE 4900B SURGICAL TABLE WAS SMOKING AT THE BASE OF THE TABLE. A REVIEW OF THE MEDWATCH INDICATES THAT THE SURGICAL TABLE IN QUESTION IS NOT A STERIS PRODUCT; STERIS CORPORATION HAS NEVER MANUFACTURED A MODEL 4900B SURGICAL TABLE. ADDITIONALLY, THE SERIAL NUMBER, (B)(4), DOES NOT MATCH THE STERIS SERIAL NUMBER CONVENTION USED BY STERIS MONTGOMERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558939 SHAMPAINE 4900B SURGICAL TABLE FQO

    Patients

    Seq Age Sex Outcome Treatment
    1