BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 16917725 · Received May 12, 2023

    Report

    Report Number
    3003768277-2023-02831
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 4, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K162859
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE STAFF MEMBER EXPERIENCED DIFFICULTIES WITH LONGITUDINAL AND LATERAL MOVEMENTS OF THE SYSTEM'S TABLE DURING THE TREATMENT OF A LARGE PATIENT (> 150 KG). THE NEXT MORNING, THE STAFF MEMBER EXPERIENCED PAIN AND NUMBNESS IN THE LEG, UNDERWENT AN MRI, AND WAS DIAGNOSED WITH A SLIGHT BULGING L4/5 DISC, AND SMALL TEARS WERE IDENTIFIED. SHE RECEIVED TREATMENT FOR THE INJURY AND FOUR MONTHS AFTER THE INCIDENT FULLY RETURNED TO WORK. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE TABLE AND SYSTEM ONSITE AND DID NOT IDENTIFY ANY ISSUES. LOG FILE ANALYSIS DID NOT DISPLAY ANY DEVICE MALFUNCTION. PHILIPS CONFIRMED THAT THE SYSTEM WAS WORKING AS INTENDED AT THE TIME OF THE REPORTED EVENT AND THE CUSTOMER CONTINUED TO USE THE SYSTEM WITHOUT ANY FURTHER REPORTS OF SIMILAR ISSUES. STANDARD OF CARE DICTATES THAT HEALTH CARE PROFESSIONALS USE PROPER BODY MECHANICS AND ERGONOMICS DURING THE REPOSITIONING, TRANSFER AND TREATMENT OF PATIENTS. NO DETAILS OF THE STAFF MEMBER¿S BODY MECHANIC RELATED TO THE REPORTED MOVEMENT OF THE TABLE WERE RECEIVED BY PHILIPS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE PATIENT BED WAS TRICKY TO MOVE AND WHILE MOVING A LARGE PATIENT ONE MEMBER OF STAFF HURT THEIR BACK. SYSTEM WAS IN CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185208 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838054189

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other