BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL DIAGNOST DUAL DETECTOR

    MDR report key: 4324520 · Received December 4, 2014

    Report

    Report Number
    3003768251-2014-00018
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH
    Product Code
    KPR
    PMA / PMN Number
    K982795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PATIENT SUPPORT IS EQUIPPED WITH A FOOT PLATE WHICH CAN BE TILTED INTO UPRIGHT POSITION. WHEN THE FIXING CLAMP FAILS THE FOOTBOARD CAN FALL DOWN. THE FIELD SERVICE ENGINEER OBSERVED THAT AN EXISTING FCO WAS NOT IMPLEMENTED AND ONE HINGE WAS DEFECTIVE. THIS RESULTED IN AN INCORRECT POSITION OF THE FOOT PLATE AND THE FIXING CLAMP CAN NO LONGER GUARANTEE A SECURE HOLD OF FOOT PLATE IN UPRIGHT POSITION. A PREVIOUS CAPA RESULTED IN THE EXISTING FCO WHICH FIX THE SECURE HOLD OF FOOT PLATE IN CASE OF DAMAGED HINGE. THE ENGINEER INSTALLED THE FCO AND REPLACED THE DEFECTIVE HINGE. THE SYSTEM WORKS AGAIN AS SPECIFIED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FRAME JOINT HINGE AT THE STITCHING PT SUPPORT BROKE ON ONE SIDE WHICH CAUSED THE FOOT PLATE OF THE PT SUPPORT TO DROP ON THE FOOT OF THE X-RAY TECH. THIS RESULTED IN THE TECHS TOE NAIL COMING OFF. NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FRAME JOINT HINGE AT THE STITCHING PATIENT SUPPORT BROKE ON ONE SIDE WHICH CAUSED THE FOOT PLATE OF THE PATIENT SUPPORT TO DROP ON THE FOOT OF THE X-RAY TECH. THIS RESULTED IN A FRACTURE OF THE TECHS TIP OF THE TOE AND NAIL COMING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784710 DIGITAL DIAGNOST DUAL DETECTOR KPR PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH 712022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other