BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD20 OR TABLE

    MDR report key: 5473350 · Received March 2, 2016

    Report

    Report Number
    3003768277-2016-00022
    Event Type
    Death
    Date Received
    March 2, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 5, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OBW
    PMA / PMN Number
    K141979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS SERVICE ENGINEER CHECKED THE LOG FILES AND FOUND THAT A STAFF MEMBER ACTIVATED THE EMERGENCY STOP ON THE ALLURA SYSTEM WHICH LOCKED THE TABLE, MAKING IT IMPOSSIBLE TO MOVE THE TABLE INTO THE TRENDELENBURG POSITION. SINCE THERE WAS NO NEED FOR THE ALLURA SYSTEM EXCEPT FOR THE FLEX VISION MONITOR WHICH WAS DISPLAYING THE PATENTS¿ VITALS, THERE WAS ONLY OPERATING ROOM STAFF IN THE ROOM AND NO CATH LAB OR RADIOLOGY STAFF. AS CONFIRMED BY THE CUSTOMER, THE OR STAFF ONLY HAD MINIMAL PARTICIPATION IN THE HANDOVER TRAINING AND WAS UNABLE TO RESET THE STOP SIGNAL. USUALLY IN SURGERY ONLY CASES THE ALLURA SYSTEM IS KEPT OFF AND THE MAQUET TABLE FUNCTIONS INDEPENDENTLY FROM IT. WHEN THE ALLURA SYSTEM IS KEPT OFF THE EMERGENCY STOP BUTTONS ON THE MCS AND TSO ARE NONFUNCTIONAL. THE STAFF SUPERVISORS HAVE BEEN INFORMED WITH A DEMONSTRATION HOW TO USE THE MAQUET TABLE AFTER THE INCIDENT. THE HOSPITAL HAS TAKEN THE ACTION TO HAVE AT LEAST ONE TRAINED MEMBER OF PERSONNEL AVAILABLE IN THE ROOM WHEN USED DURING MEDICAL PROCEDURES. ACCORDING THE HOSPITAL STAFF THE SYSTEM DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN THE INVESTIGATION IS COMPLETED PHILIPS WILL INFORM THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER IN WHICH THEY STATED THAT A PATIENT DIED AFTER SURGERY. AFTER THE PROCEDURE WAS FINISHED THE PATIENT NEEDED TO BE TILTED HEAD DOWN TO RECOVER FROM ANESTHESIA THE TABLE COULD NOT BE MOVED BECAUSE E-STOP WAS ACCIDENTLY ACTIVATED BY THE STAFF AND NO ONE NOTICED. AT THIS MOMENT IT'S STILL UNCLEAR IF THIS CAUSED THE DEATH OF THE PATIENT. AS THIS IS A HYBRID SYSTEM THE TABLE CAN USED AS STANDALONE DEVICE FOR SURGERY, THE ALLURA SYSTEM WAS NOT USED FOR THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130538 ALLURA XPER FD20 OR TABLE ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER OBW PHILIPS HEALTHCARE 722035

    Patients

    Seq Age Sex Outcome Treatment
    1 Death