BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 857529 · Received May 29, 2007

    Report

    Report Number
    3019090-2007-00002
    Event Type
    Other
    Date Received
    May 29, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 4, 2007
    Manufacturer
    GETINGE USA, INC [F.K.A. ALM SURGICAL EQUIP (CA)]
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION FROM EXAMINATION OF UNIT IS THAT THE COVER PLATE AND LATCH CLIPS BECOME BENT ALLOWING THE BACK COVER PLATE TO FALL OFF THE LIGHTHEAD WHEN LIGHT IS BEING REMOVED FROM DOCKING PORT. STAFF AT THE FACILITY WERE UNABLE TO CONFIRM IF THE DOCTOR ACTUALLY WAS HIT OR IT WAS A NEAR MISS. NO INJURY WAS REPORTED. THE LAMP COVER PLATE IS EFFECTIVELY TETHERED WITH A GROUNDING STRAP TO THE LIGHTHEAD TO LIMIT ITS FALLING DISTANCE AND ITS SWING. GETINGE USA, INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. GETINGE USA, INC PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    WHILE REMOVING THE LIGHTHEAD FROM THE DOCKING PORT THE LAMP COVER PLATE FELL OFF THE LIGHTHEAD AND IT WAS REPORTED THAT IT PPOSSIBLY STRUCK THE PHYSICIAN IN THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FSY GETINGE USA, INC [F.K.A. ALM SURGICAL EQUIP (CA)] LDR AX-4

    Patients

    Seq Age Sex Outcome Treatment
    1 YR