BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20

    MDR report key: 9472885 · Received December 16, 2019

    Report

    Report Number
    3003768277-2019-00103
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 28, 2019
    Report Date
    November 28, 2019
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THIS COMPLAINT. PHILIPS HAS CONFIRMED WITH THE CUSTOMER THAT THE PATIENT HAD PRE-EXISTING MEDICAL CONDITIONS OF CEREBRAL INFARCTION AND POOR MUSCLE STRENGTH ON THE RIGHT SIDE. THE PLANNED CORONARY PROCEDURE WAS NOT STARTED ON THE DATE OF THE INCIDENT. DESPITE THE GOOD FAITH EFFORT PERFORMED BY PHILIPS, NO INFORMATION HAS BEEN PROVIDED TO PHILIPS ON THE FINAL PATIENT OUTCOME. PHILIPS HAS CONFIRMED THAT THE CUSTOMER WAS USING A LEATHER COVER OVER THE MATTRESS OF THE AD7 TABLE. THIS COVER ENVELOPED ALMOST THE ENTIRE PHILIPS MATTRESS (TOP AND BOTTOM). THIS COVER WAS NOT PROVIDED BY PHILIPS. WHEN A COVER IS USED, PHILIPS CANNOT GUARANTEE THE FIXATION OF THE MATTRESS TO THE TABLETOP. PHILIPS HAS NOT BEEN ABLE TO CONFIRM THE EXACT CAUSE OF THE FALL. THE FALL OCCURRED DURING THE PREPARATORY PHASE OF THE PROCEDURE AND WAS NOT OBSERVED BY THE OR TEAM. PHILIPS INFORMED THE CUSTOMER THAT IN ORDER TO SECURE THE PATIENT PHILIPS PROVIDES ADDITIONAL PATIENT FIXATION LIKE PATIENT STRAPS AND RATCHET COMPRESSORS, AS DESCRIBED IN THE INSTRUCTIONS FOR USE (9896 002 02285) PAGE 2.41. BASED ON THE INVESTIGATION RESULTS, PHILIPS HAS CONCLUDED THAT THERE WAS NO MALFUNCTION OF THE SYSTEM. CONSEQUENTLY, PHILIPS HAS CLOSED THIS COMPLAINT. 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

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING THE PREPARATION PHASE FOR CLINICAL PROCEDURE, THE PATIENT FELL OFF THE OPERATING ROOM TABLE, CAUSING A LACERATION AND A CEREBRAL HEMORRHAGE. THE PATIENT RECEIVED TREATMENT FOR BOTH INJURIES. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268671 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722012

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening