BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2613515 · Received May 23, 2012

    Report

    Report Number
    9710055-2012-00009
    Event Type
    Malfunction
    Date Received
    May 23, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH (FST) VISITED THE FACILITY TO EVALUATE THE DEVICE AND FOUND THAT THE METAL SAFETY RING AT THE JUNCTION BETWEEN THE CUPOLA AND THE SPRING ARM WAS NOT POSITIONED CORRECTLY. IT WAS SEATED ABOVE THE RETAINING SCREW. NOTE: THE CUPOLA IS CONNECTED TO THE SPRING ARM BY USE OF A RETAINING PIN WITH A PROTECTIVE COLLAR OR "RING" COVERING THE PIN WHICH PREVENTS IT FROM BEING DISLODGED. THE RING IS SECURED BY MEANS OF RETAINING SCREW. WITHOUT THIS RING IN PLACE, THE PIN CAN BECOME DISLODGED AND THE CUPOLA MAY DETACH FROM THE SPRING ARM WHEN MANIPULATED BY THE SURGEON. PLEASE FURTHER NOTE THAT IF THIS RING IS NOT IN PLACE, ANY UPWARD MOVEMENT OF THE RIGHT WOULD BE SUFFICIENT TO DISLODGE THE CUPOLA. THE LIGHT HAD BEEN IN USE FOR A MONTH PRIOR TO THE INCIDENT WITHOUT BECOMING DISLODGED. CONSEQUENTLY MAQUET INTERVIEWED (B)(6) TO DETERMINE IF ANYONE HAD MOVED THE RETAINING RING DURING THEIR CLEANUP OF THE LIGHT. (B)(6) REPORTED THAT THEY HAD NOT ADJUSTED THE RING. MAQUET ALSO REVIEWED THE INSTALLATION RECORDS AND FOUND NO ABNORMALITIES. MAQUET WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE INCORRECT PLACEMENT OF THE METAL SAFETY RING/COLLAR. HOWEVER, AS A PRECAUTION, THE MAQUET SERVICE REP INSPECTED ALL MAQUET LIGHTS AND MONITOR HOLDING ARMS AT THIS HOSPITAL AND FOUND NO FURTHER INSTANCES OF INCORRECTLY MOUNTED COLLARS. (B)(4). MAQUET MEDICAL 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 A SURGICAL CUPOLA DETACHED WHEN BEING POSITIONED. THE CUSTOMER WAS ABLE TO CONTROL THE DECENT OF THE LIGHT AS IT FELL BUT THE CUPOLA GLANCED OFF OF DR'S HEAD ON THE WAY DOWN; NO INJURIES WERE REPORTED AND HE WAS ABLE TO CONTINUE THE SURGERY. THE LIGHT HEAD DID NOT STRIKE THE PT NOR WAS THE STERILE FIELD COMPROMISED; THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INTERRUPTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FSY MAQUET SAS POWERLED

    Patients

    Seq Age Sex Outcome Treatment
    1