BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 4180571 · Received October 15, 2014

    Report

    Report Number
    9710055-2014-00086
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MAQUET S.A.S
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Removal / Correction Number
    NA
    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 COMPATIBILITY WITH THE STERILIZED HANDLES USED BY THIS FACILITY. THE CAUSE OF THIS EVENT IS THE CLIP - PART OF THE LOCKING SYSTEM FROM THE HANDLE SUPPORT- HAS BROKEN AND THEN DISLODGED FROM ITS LOCATION WHILE USER WAS MANIPULATING THE LIGHT. HOWEVER MAQUET DID NOT DETERMINED YET WHY THE CLIP HAS BROKEN. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE HANDLE SUPPORT HAS BEEN REPLACED WITH A NEW ONE AND UNIT RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LOCKING SYSTEM, FROM THE HANDLE SUPPORT, FELL OFF FROM THE CUPOLA WHLIE REMOVING THE HANDLE DURING THE CLEANING PROCESS. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655774 POWERLED FSY MAQUET S.A.S NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA