BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHASTAR

    MDR report key: 1590949 · Received January 27, 2010

    Report

    Report Number
    MW5014560
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 27, 2010
    Manufacturer
    MAQUET
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE METAL ON AN OPERATING ROOM TABLE BROKE IN HALF, RESULTING IN COLLAPSE OF A SEGMENT OF THE OR TABLE WITH A PT ON IT. AN EVAL OF EIGHT OF THE SAME TABLES IN OUR OPERATING ROOM AND LABOR AND DELIVERY ROOMS REVEALED LINEAR DEFECTS OR FRACTURES IN THE SAME AREA ON THESE TABLES AS THE BROKEN TABLES. SURGERY WAS CANCELLED FOR THE PT INVOLVED. PT WAS AWAKENED FROM THE ANESTHESIA AND INFORMED OF WHAT OCCURRED. RADIOLOGY STUDIES PERFORMED TO EVALUATE FOR INJURIES; SURGERY TO BE RESCHEDULED. DATES OF USE: (B) (6) 2004 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHASTAR OR TABLE FQO MAQUET 1132.01.B3

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization