BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 2501641 · Received February 28, 2012

    Report

    Report Number
    1523530-2012-00007
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MIDMARK CORP.
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STEP INVOLVED WAS RETURNED AND EXAMINED. IT WAS FOUND THAT ONE OF THE SLIDES HOLDING THE STEP TO THE TABLE WAS OUT OF SPECIFICATIONS. THE CAUSE APPEARS TO BE THAT THE STEP WAS EITHER DAMAGED DURING INSTALLATION OR ABUSED DURING USE.

    Description of Event or Problem · 1

    PATIENT FELL OFF OF TABLE STEP. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITTER EXAMINATION TABLE FQO MIDMARK CORP. 204-001

    Patients

    Seq Age Sex Outcome Treatment
    1