BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECHO TABLE

    MDR report key: 2108205 · Received May 16, 2011

    Report

    Report Number
    1932056-2011-00005
    Event Type
    Other
    Date Received
    May 16, 2011
    Date of Event
    February 25, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    IZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL IT WAS NOTED THAT THE CAUSE OF THE PROBLEM WAS A "COLD WELD" WHICH DIDN'T PENETRATE PROPERLY AND WAS ABLE TO SEPARATE WHEN WEIGHT WAS APPLIED TO THE PRODUCT. MPI OPENED (B)(4) TO INVESTIGATE THE ISSUE TO DETERMINE THE ROOT CAUSE FOR THE PROBLEM, AND TO DETERMINE IF A FIELD CORRECTION IS NECESSARY FOR THE ISSUE.

    Description of Event or Problem · 1

    THE TABLE WAS IN USE AND NEITHER A PT NOR USER-FACILITY STAFF MEMBER WERE INJURED DURING THE EVENT, MPI FEELS THAT A RECURRENCE OF THE EVENT WITH A PT ON THE PRODUCT COULD LEAD TO AN ADVERSE EVENT. A CRITICAL WELD ON THE PRODUCT WAS BROKEN WHEN WEIGHT WAS APPLIED TO THE TABLE BY THE PLACEMENT OF INANIMATE OBJECTS ON THE TABLE. THE WELD SEPARATION CAUSED THE HEAD END OF THE TABLE TO FALL TO THE FLOOR. IF THIS HAD OCCURRED WHILE IN USE WITH A PT, THE EVENT COULD HAVE LEAD TO CONTUSIONS AND BRUISING FROM SUCH A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO TABLE ECHOCARDIOGRAPHY PROCEDURE TABLE IZZ MEDICAL POSITIONING, INC. 1283

    Patients

    Seq Age Sex Outcome Treatment
    1