BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALYPSO 4D LOCALIZATION SYSTEM

    MDR report key: 1725672 · Received May 27, 2010

    Report

    Report Number
    3004837948-2010-00002
    Event Type
    Other
    Date Received
    May 27, 2010
    Date of Event
    April 28, 2010
    Report Date
    May 27, 2010
    Manufacturer
    CALYPSO MEDICAL TECHNOLOGIES, INC.
    Product Code
    IYE
    PMA / PMN Number
    K060906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION TO DATE; NO INJURIES WERE INCURRED AS A RESULT OF THE CASTER BREAKING AT (B)(6) HOSPITAL. THIS CASTER IS A YELLOW-COLORED CASTER THAT WAS MANUFACTURED BY A THIRD-TIER SUPPLIER IN (B)(4). THE MFR OF THE CASTER IS OF THE OPINION THAT THE FAILURE IS FROM ABUSE. CALYPSO HAS NOT EXCEEDED THE MFR'S LOAD GUIDANCE. (B)(4). IN ADDITION, THE MFR CONFIRMED THAT MEDICAL PRODUCTS OF SIMILAR SIZE AND MASS TO CALYPSO MEDICAL'S USE THIS CASTER WITHOUT INCIDENT. THE FAILURE MODE INVESTIGATION WAS PERFORMED BY AN INDEPENDENT TEST FACILITY. THE FAILURE ANALYSIS RESULTS SHOWED THE FRACTURE FEATURES INDICATED A SINGLE EVENT FAILURE. NO FATIGUE OR SIGNIFICANT MATERIAL FLAWS WERE OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A CASTER BROKE. THIS PARTICULAR SITE HAS CARPET AND TILE IN THE TREATMENT ROOM AND THE CONSOLE IS WHEELED OVER THE CARPET TO TILE THRESHOLD ON A DAILY BASIS. INVESTIGATION FOUND THE THRESHOLD TO BE EXCESSIVELY HIGH (5/8"). THE SUBJECT FAILURE OCCURRED WHEN THEY WERE PULLING THE CONSOLE OVER THE THRESHOLD FOR MORNING QA. SUBSEQUENT DISCUSSION WITH THE RTT REVEALED THAT SHE USES "A RUNNING START" TO GET THE CONSOLE OVER THE THRESHOLD AND THAT SHE HAD COMPLAINED TO HER SUPERVISOR ABOUT THE THRESHOLD. CROSSING THE THRESHOLD IN ITSELF IS NOT AN ISSUE IF THE UNIT IS PUSHED/PULLED OVER THE THRESHOLD IN A CONTROLLED MANNER, BUT THE USE OF A RUNNING START IS NOT WITHIN NORMAL OR EXPECTED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALYPSO 4D LOCALIZATION SYSTEM PATIENT LOCALIZATION SYSTEM IYE CALYPSO MEDICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1