BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 8188893 · Received December 21, 2018

    Report

    Report Number
    3003768277-2018-00098
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Report Date
    December 6, 2018
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. THE REVIEW OF THE LOG FILES OF JULY 31, 2018 SHOWED THAT THE EMERGENCY STOP OF THE SYSTEM WAS PRESSED AT 19:03H AND WAS ON UNTIL THE SYSTEM WAS SHUT DOWN AT 23.35H ON THAT DAY. WHEN THE EMERGENCY STOP IS ACTIVATED, THE MOTORIZED MOVEMENT IS NOT AVAILABLE AND THE TABLETOP IS FLOATING. WHEN THE PROCEDURE WITH THE PATIENT STARTED, THE EMERGENCY STOP WAS ACTIVE AND THEREFORE THE MOTORIZED MOVEMENTS WERE NOT AVAILABLE AND THE TABLETOP WAS FLOATING. IT IS UNKNOWN WHY THE EMERGENCY STOP WAS PRESSED. THE LOG FILES SHOWED THAT TWO WARNINGS WERE PROMPTED BY THE SYSTEM ¿WARNING: EMERGENCY STOP ACTIVATED; RESET TO CONTINUE¿ (WHEN THE EMERGENCY STOPE WAS PRESSED) AND ¿WARNING: MOTORIZED MOVEMENT UNAVAILABLE¿ (WHEN THE PROCEDURE STARTED). THE SYSTEM WAS STARTED ON THE NEXT DAY AND THE MOTORIZED MOVEMENT WAS AVAILABLE. NO MALFUNCTION OF THE GEOMETRY/TABLE HAS BEEN IDENTIFIED. NO FURTHER ACTIONS WILL BE TAKEN BY PHILIPS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

    Description of Event or Problem · 1

    PHILIPS HAS RECEIVED THROUGH (B)(6) A REPORT SUBMITTED ((B)(4)) BY A CUSTOMER. IN THIS REPORT THE CUSTOMER REPORTED: ¿THE X-RAY TUBE IN ROOM 5 HAD BEEN REPAIRED, UPDATED DURING THE DAY OF (B)(6) 2018. WAS REPORTED READY FOR USE. WE RE-BOOTED THE SYSTEM AT THE BEGINNING OF THE NIGHT SHIFT DUE TO THAT THE TABLE WAS HARD TO OPERATE (A CREAKING SOUND). HEREAFTER THERE WAS AN ACUTE PATIENT ON THE TABLE WITHOUT X-RAY PROBLEMS. AFTER SOME HOURS A NEW ACUTE PATIENT ARRIVE. BEFORE THIS PATIENT WAS BROUGHT ONTO THE TABLE WE DISCOVERED THAT THE TABLE WAS FLOATING ¿ MEANING THAT IT WAS MOVING BY THE LEASED TOUCH. THEREFORE IT WAS NOT POSSIBLE TO COMPLETE THE KAG/PCI ON THIS VERY BAD ACUTE PATIENT. HAD TO MOVE THE PATIENT TO ANOTHER ROOM WHICH TOOK APPROX. 10 MIN. NORMALLY ¿ WHEN TREATING ACUTE PATIENTS ¿ IT TAKES APPROX.. 5 MIN WHEN THE PATIENT ARRIVE AT THE ROOM UNTIL THE PROCEDURE CAN START¿. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030097 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS HEALTHCARE 722010

    Patients

    Seq Age Sex Outcome Treatment
    1