BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 2240909 · Received August 8, 2011

    Report

    Report Number
    1523530-2011-00024
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MIDMARK CORP.
    Product Code
    GBB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED BY THE HOSPITAL BIOMEDICAL ENGINEER AND THE TILT ACTUATOR WAS DISCARDED BEFORE IT COULD BE RETURNED FOR EVAL. PHOTOGRAPHS OF THE ACTUATOR SHOWED THAT THE ALUMINUM CASTING WHICH HOLDS THE ACTUATOR TO THE BASE HAD BROKEN IT IS NOT CLEAR WHAT CAUSED THE BREAK.

    Description of Event or Problem · 1

    THE TILT ACTUATOR ON THE TABLE BROKE ALLOWING THE TABLE TOP TO TILT BACK. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDMARK CHAIR, SURGICAL, AC-POWERED GBB MIDMARK CORP. 630-001

    Patients

    Seq Age Sex Outcome Treatment
    1