BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 1934168 · Received December 8, 2010

    Report

    Report Number
    9681684-2010-00056
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BHM MEDICAL INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS WAITING FOR THE RETURN OF THE DEFECTIVE PARTS AND FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A SERVICE VISIT AT THE FACILITY, AN ARJOHUNTLEIGH ENGINEER (MFR'S SALES UNIT) NOTICED AN OPERA LIFT WITH A BOOM SLIGHTLY BENT BACKWARDS. ON CLOSER INSPECTION, IT WAS FOUND THE T-BAR (SPREADER BAR'S ATTACHMENT SYSTEM) HAD STARTED TO DETACH FROM THE BOOM. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERA LIFT, PATIENT, NON AC POWERED FSA BHM MEDICAL INC. KPA0300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other