BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YSIO

    MDR report key: 15349704 · Received September 2, 2022

    Report

    Report Number
    3004977335-2022-42153
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 26, 2022
    Report Date
    December 28, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    KPR
    PMA / PMN Number
    K081722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FACILITY CONTACT NAME AND PHONE NUMBER WERE NOT PROVIDED TO SIEMENS. MANUFACTURERS PRELIMINARY ANALYSIS: INVESTIGATION IS ON-GOING. INITIAL CORRECTIVE ACTIONS/PREVENTIVE ACTIONS IMPLEMENTED BY THE MANUFACTURER: NO INDICATION FOR A GENERAL ISSUE IS AVAILABLE. DESPITE ON-SITE SUPPORT, NO FURTHER IMMEDIATE ACTIONS DEEMED NECESSARY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID# (B)(4).

    Additional Manufacturer Narrative · 0

    H10 MANUFACTURER NARRATIVE: THE REPORTED EVENT WAS INVESTIGATED IN DETAIL. IT WAS INITIALLY REPORTED THAT THE PATIENT STEPPED ONTO THE METAL ORTHO SUPPORT STEP WHICH WAS LOOSE. THE STEP MOVED AND AS A RESULT, THE PATIENT FELL AND HURT HIS SHOULDER. ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT WAS IMMEDIATELY EXAMINED BY A PHYSICIAN, BUT NO SERIOUS INJURY SEEMED TO HAVE OCCURRED. THE PATIENT'S HEALTH STATUS WAS NOT AVAILABLE TO SIEMENS WHEN THE INITAL REPORT WAS SUBMITTED TO THE FDA ON SEPTEMBER 2, 2022. THE PROVIDED PICTURES WERE ANALYZED. IT WAS OBSERVED IN THE PHOTOGRAPHS THAT THE RUBBER FEET OF THE ORTHO SUPPORT STEP WERE NO LONGER PRESENT. THESE GLUED-ON RUBBER FEET SERVE AS PROTECTION SO THAT THE PAINTED METAL SURFACES CANNOT TOUCH EACH OTHER AND THUS AS A PROTECTION OF THE SURFACE FROM SCRATCHES. THE RUBBER FEET ARE NOT INTENDED TO HOLD THE ORTHO SUPPORT STEP SECURELY. THE AFFECTED ORTHO SUPPORT STEP WAS REQUESTED FOR FURTHER INVESTIGATION. IT WAS CONFIRMED THAT ALL FOUR RUBBER FEET WERE MISSING. THERE WERE ADHESIVE RESIDUES AT THE POINTS WHERE THE RUBBER FEET WERE ATTACHED. ACCORDING TO THE SERVICE ORGANIZATION, THE ORTHO SUPPORT STEP WAS FIXED TO THE ORTHO STAND WITH VELCRO TAPE AFTER THE INCIDENT DESCRIBED. ALTHOUGH THIS FIXES THE ORTHO SUPPORT STEP IN POSITION, IT IS NOT A PERMANENT SOLUTION DUE TO THE NON-ORIGINAL STATE OF THE ORTHO SUPPORT STEP. THE VIDEO PROVIDED SHOWS THAT THE ORTHO SUPPORT STEP COULD SLID WHEN STEPPED ON IN THE DIRECTION OF THE ORTHO SUPPORT BACKWALL. IF THE ORTHO SUPPORT STEP IS PLACED CORRECTLY CLOSE TO THE ACRYLIC PLATE BETWEEN THE TWO COLUMNS AND IN THE CORRECT DIRECTION, IT IS VERY UNLIKELY THAT IT WILL SLIP AWAY. IT IS THEREFORE ASSUMED THAT THE ORTHO SUPPORT STEP WAS NOT CORRECTLY PLACED ON THE ORTHO STAND WHEN THE PATIENT FELL. THE CORRECT PLACING OF THE ORTHO SUPPORT STEP IS DESCRIBED IN THE OPERATOR MANUAL (SEE XPB7-010.620.01.02.02, CHAPTER "ORTHO" ON PAGE 171). ACCORDING TO THE RECEIVED INFORMATION, THE AFFECTED ORTHO SUPPORT STEP WAS REPLACED ON SITE. THE SPARE PART CONSUMPTION OF THE AFFECTED PART (MATERIAL NUMBER 8900057) SHOWS VALUES BELOW THE DEFINED THRESHOLD. DURING REPLACEMENT, THE SERVICE ENGINEER FOUND TWO RUBBER FEET THAT WERE OUT OF PLACE. THESE RUBBER FEET WERE SECURED WITH SUPER GLUE. AFTER THAT, THE SYSTEM WAS HANDED OVER TO THE CUSTOMER. THE COMPLAINT IS CLOSED. ADDITIONAL MEASURES BY SIEMENS ARE NOT DEEMED NECESSARY. H11 CORRECTED DATA: D8: DEVICE WAS SERVICED BY SIEMENS AND SHOULD HAVE BEEN CHECKED "NO" ON THE INITIAL REPORT SUBMITTED TO THE FDA ON SEPTEMBER 2, 2022. H8: USAGE OF DEVICE WAS INCORRECTLY CHECKED AS "REUSE" IN INITIAL REPORT. THIS FIELD SHOULD HAVE BEEN BLANK.

    Additional Manufacturer Narrative · 0

    G4: 510(K) REPORTED INITIALLY WAS INCORRECT. THE 510(K) OF THE COMPLAINT SYSTEM WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL FROM THE ORTHO SUPPORT STEP AND HURT THEIR SHOULDER. THE METAL SUPPORT STEP APPEARED TO BE LOOSE. THE ORTHO SUPPORT STEP IS A SOLID COMPONENT WITH FOUR (4) RUBBER FEET. THE RUBBER FEET WERE REPORTEDLY WORN. THE DETAILS REGARDING THE EXTENT OF THE PATIENT'S INJURY ARE NOT KNOWN, THEREFORE, SIEMENS HAS CLASSIFIED IT AS A MODERATE INJURY. IN A WORST-CASE SCENARIO, A SERIOUS INJURY COULD RESULT IF THE EVENT WERE TO REOCCUR. THE REPORTED EVENT OCCURRED IN THE UNITED KINGDOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143357 YSIO SYSTEM, X-RAY, STATIONARY KPR SIEMENS HEALTHCARE GMBH 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other