BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD

    MDR report key: 14160142 · Received April 20, 2022

    Report

    Report Number
    3003768277-2022-00169
    Event Type
    Death
    Date Received
    April 20, 2022
    Date of Event
    April 11, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059061
    PMA / PMN Number
    K130842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE TABLE PIVOTED DURING CPR. CPR COULD BE PERFORMED WHILE ANOTHER PERSON WAS HOLDING THE TABLE IN PLACE. THE HOSPITAL¿S MEDICAL RADIATION TECHNOLOGIST CONFIRMED THAT THE REPORTED PROBLEM DID NOT CONTRIBUTE TO THE PATIENT PASSING AWAY. CPR WAS PERFORMED WITH THE DETECTOR IN THE PATIENT AREA, CAUSING THAT CPR WAS PERFORMED SIDEWAYS. WHEN PERFORMING CPR SIDEWAYS, THE FORCE EXERTED ON TABLE IS ALSO SIDEWAYS, WHICH MAY CONTRIBUTE TO THE TABLE PIVOTING DURING CPR. THE INSTRUCTIONS FOR USE PROVIDE THE ADVICE TO PIVOT THE TABLE TO PROVIDE CLEAR ALL-ROUND ACCESS TO THE PATIENT WHEN PERFORMING CPR. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ONSITE, MEASURED THE FORCE NEEDED TO PIVOT THE TABLE AND CONFIRMED THAT IT WAS WITHIN SPECIFICATION. TO INCREASE THE FORCE NEEDED TO MOVE THE PIVOT, THE PIVOT FRICTION LOCK WAS ADJUSTED. PHILIPS CONCLUDES THAT THERE WAS NO MALFUNCTION OF THE SYSTEM. AS THE SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH, PHILIPS EVALUATES THIS COMPLAINT AS NOT REPORTABLE. CORRECTED DATA: THE REPORT HAS BEEN UPDATED TO ADVERSE EVENT ONLY AS THERE HAS BEEN NO PRODUCT PROBLEM IDENTIFIED. PATIENT INFORMATION HAS BEEN UPDATED. THE CODES HAVE BEEN UPDATED TO REFLECT THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT AFTER COMPLETING A PROCEDURE, THE PATIENT WENT INTO A CARDIAC ARREST. WHEN THE HOSPITAL STAFF PERFORMED CPR, THE PATIENT TABLE MOVED. THE PATIENT PASSED AWAY. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648883 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 BIPLANE 00884838059061

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death