BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 3856308 · Received April 10, 2014

    Report

    Report Number
    1523530-2014-00007
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MIDMARK CORP.
    Product Code
    LGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED AT THIS TIME. A SITE EVAL WAS PERFORMED BY A TECH. THE SITE INDICATED THAT THE CAUTERIZATION EQUIPMENT CAUSED A SHOCK WHEN A PT CAME IN CONTACT WITH A DIFFERENT PRODUCT, DESCRIBED AS A CART. THE CAUTERIZATION MACHINE WAS PLUGGED INTO A WALL OUTLET, NOT THE OUTLET PROVIDED FOR MEDICAL EQUIPMENT ON THE MIDMARK 630. A RECOMMENDATION WAS GIVEN TO THE SITE TO EVAL THE CAUTERIZATION EQUIPMENT FOR PROPER CONSTRUCTION. THE SITE DID NOT GIVE MODEL INFO ON THE CAUTERIZATION EQUIPMENT AT THE TIME OF THIS REPORT. BASED ON THE SITE EVAL, MIDMARK IS ABLE TO CONFIRM THAT THE MIDMARK 630 EXAMINATION TABLE WAS NOT THE CAUSE OF THE PT SHOCK.

    Description of Event or Problem · 1

    (B)(6), MD'S OFFICE REPORTED THAT A PT RECEIVED A SHOCK DURING A PROCEDURE FROM A CAUTERIZATION EQUIPMENT WHEN THEY TOUCHED THE MIDMARK 630 EXAMINATION TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216524 MIDMARK EXAMINATION TABLE LGX MIDMARK CORP. 630-004

    Patients

    Seq Age Sex Outcome Treatment
    1