BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET SA

    MDR report key: 1848528 · Received September 14, 2010

    Report

    Report Number
    9710055-2010-00011
    Event Type
    Other
    Date Received
    September 14, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH VISITED THE HOSPITAL, AND EVALUATED THE DEVICE. HE FOUND THAT THE C-CLIP THAT SECURES THE LIGHT HEAD TO THE MAIN ARM WAS OUT OF ITS GROVE. BECAUSE THE C-CLIP WAS NOT SEATED IN ITS SAFETY POSITION, THE LIGHT HEAD WAS ALLOWED TO SLIP DOWN AND FALL OVER TIME. THE FIELD SERVICE TECH EVALUATED THE C-CLIP AND THE GROOVE, BUT NO ANOMALIES WERE FOUND. HE ALSO VERIFIED THE OTHER THREE SIMILAR DEVICES IN THE HOSPITAL AND DID NOT FIND ANY ABNORMALITIES. THE HOSPITAL DECIDED TO DISCARD THE DEVICE AND REPLACE IT WITH A NEW ONE. ECL SERIES PREVENTIVE MAINTENANCE PROGRAM REQUIRES OPERATORS TO VERIFY THE PRESENCE OF THE SAFETY CLIPS. PREVENTIVE MAINTENANCE IN THIS HOSPITAL IS UNDER MAQUET'S RESPONSIBILITY. THIS DEVICE WAS LAST VERIFIED IN (B)(4) 2009, AND NO ABNORMALITIES WERE REPORTED. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE LIGHT HEAD DISSOCIATED FROM THE MAIN SUSPENSION ARM DURING CLEANING, AND FELL ONTO THE FLOOR. NO INJURIES WERE REPORTED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1