BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWD

    MDR report key: 6438553 · Received March 28, 2017

    Report

    Report Number
    9710055-2017-00018
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 28, 2017
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE AND FOUND THAT THE ROOT CAUSE OF THIS EVENT IS A COLLISION WITH A LUMINAIRE ARM. ADDITIONALLY THE DEVICE WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT AND WAS BEING USED FOR TREATMENT OR DIAGNOSIS OF THE PATIENT WHEN THE EVENT OCCURRED. THE HOSPITAL TECHNICIAN IMMEDIATELY COVERED THE OPERATING AREA AND THE NURSE SEALED THE OPEN END OF THE SUSPENSION WITH A SELF-ADHESIVE PLASTIC SHEATH. THE PERIODIC MAINTENANCE PROGRAM IN THE POWERLED OPERATING MANUAL INSTRUCTS TO CHECK FOR ANY LOOSE COVERS AND CAPS. THE USER MANUAL INDICATES THAT USERS SHOULD CHECK FOR IMPACTS MARKS OR ANY OTHER DAMAGES ON THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, DURING SURGERY, THE RUBBER BUMPER OF THE CEILING SUSPENSION FELL DOWN. IT DID NOT FALL ON THE PATIENT OR THE OPERATING FIELD. THERE WERE NO INJURIES REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220609 PWD LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS PWD75+DFVK3

    Patients

    Seq Age Sex Outcome Treatment
    1