BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1459508 · Received August 21, 2009

    Report

    Report Number
    9710055-2009-00009
    Event Type
    Other
    Date Received
    August 21, 2009
    Date of Event
    July 22, 2009
    Report Date
    July 22, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MAQUET REPRESENTATIVE VISITED THE HOSP AND EVALUATED THE DEVICE. HE FOUND THAT THE SAFETY PIN, LOCKING THE LOWER ARM TO THE UPPER ARM, WAS ABSENT. ABSENCE OF THIS PIN ALLOWED THE LOWER ARM TO BECOME UNSCREWED FROM THE UPPER ARM. MAQUET SERVICE RECOMMEND THE REPLACEMENT OF THE LIGHT. THE HOSP STAFF HAS FACILITATED AN INTERMEDIATE REPAIR TO ENSURE NO FUTURE PROBLEMS, AND IS PRESENTLY IN NEGOTIATIONS WITH MAQUET TO PURCHASE A REPLACEMENT. VERIFYING THE PRESENCE OF THIS PIN IS PART OF THE ECL PREVENTIVE MAINTENANCE PROGRAM. THIS CUSTOMER IS NOT UNDER MAINTENANCE CONTRACT WITH MAQUET, AND NO MAINTENANCE RECORD HAS BEEN PRESENTED. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    PT WAS ON OR TABLE AND HAD BEEN ANESTHETIZED, BUT THE SURGICAL PROCEDURE HAD NOT BEGUN. THE LIGHT FELL. NURSE SAW IT HAPPEN AND TRIED TO MINIMIZE THE IMPACT. LIGHT CUPOLA HIT PT'S LEGS. THE HOSP DID NOT REPORT ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FTD MAQUET S.A. ECL

    Patients

    Seq Age Sex Outcome Treatment
    1