BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 4093137 · Received August 21, 2014

    Report

    Report Number
    9710055-2014-00064
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MAQUET S.A.S
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET DETERMINED THAT THE CUSTOMER DID NOT USE THE ORIGINAL POWERLED HANDLE SUPPORT PROVIDED BY THE MFR. IT WAS REPLACED DURING THE INSTALLATION WITH A DIFFERENT MODEL, IN ORDER TO ALLOW COMPATABILITY WITH THE STERILIZED HANDLES USED BY THIS FACILITY. THE CAUSE OF THIS EVENT IS THE RETAINING CLIP - PART OF THE SUBSTITUTE HANDLES INTERFACE - NOT BEING CORRECTLY SEATED IN ITS GROOVE FROM THE SUPPLIER. DUE TO THIS ASSEMBLY ERROR, THE CLIP WAS ABLE TO SLIP OUT AND DISLODGE FROM ITS LOCATION WHILE USER WAS MANIPULATING THE LIGHT. THE DEFECTIVE HANDLE SUPPORT HAS BEEN REPLACED BY THE CUSTOMER WITH A NEW ONE, ASSEMBLY VERIFIED TO BE SAFE, AND UNIT RETURNED TO SERVICE. MAQUET MED SYSTEMS USA 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

    THE CUSTOMER REPORTED TO MAQUET THAT WHEN REPLACING A STERILE HANDLE OF AN OPERATING LIGHT, DURING SURGERY, THE CIRCLIP AND THE HANDLE FELL DOWN. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506762 POWERLED FSY MAQUET S.A.S NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA