BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XRAY2GO

    MDR report key: 21356321 · Received August 12, 2016

    Report

    Report Number
    3012411108-2016-00001
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 12, 2016
    Manufacturer
    OSSTEM IMPLANT CO. LTD. CHAIR BUSINESS
    Product Code
    EHD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WILL CONDUCT PREINVESTIGATION FOR THIS MATTER AFTER RECEIVING THE SUBJECT DEVICES FROM THE DISTRIBUTOR (DEALER). THE COUNTER-PLAN MEETING WAS HELD IMMEDIATELY AS SOON AS IT WAS REPORTED FROM THE DISTRIBUTOR WITH THE IMAGES AND REPORT. THE SUPPLIER AND MANUFACTURER FOUND THAT THE BATTERY WAS CHARGED OVER (B)(4) AND THE BATTERY CELL BALANCE HAD BEEN BROKEN DOWN FROM ANY EXTERNAL IMPACT DURING DELIVERY. BUT FULL INVESTIGATION WILL BE NEEDED TO DETERMINE THE CAUSE. THE INVESTIGATION WILL BE CONDUCTED BY INTERNATIONAL CERTIFIED TESTING LABORATORY. THE MANUFACTURER REQUESTED THE RETURN OF ALL OF THE SAME BATCH OF THE SUBJECT DEVICES AND STORED WAREHOUSE DEVICES EXCEPT FOR THE (B)(4) DEVICES TO THE IMPORTER AND DISTRIBUTOR. THE (B)(4) DEVICES MENTIONED WERE DIFFERENT BATCH AND SENT TO DISTRIBUTOR UPON THEIR REQUEST.

    Description of Event or Problem · 0

    THE DISTRIBUTOR ((B)(4)) INFORMED US OF THIS INCIDENCE WHEN IT'S HAPPENED AT THEIR WAREHOUSE. ACCORDING TO THEIR NARRATIVE "THEY RECEIVED A NEW BATCH OF XRAY2GO FROM HIOSSEN OUT OF (B)(6). IT WAS A BATCH OF (B)(4) UNITS BUT UNFORTUNATELY, ONE OF THE UNITS, THE EXTERNAL BATTERY MORE SPECIFICALLY EXPLIDED AND MELTED ALL THE PARTS INSIDE THE BOX AND BURNED THE ALUMINUM CASE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526373 XRAY2GO PORTABLE X-RAY SYSTEM EHD OSSTEM IMPLANT CO. LTD. CHAIR BUSINESS EXARO DXR1607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown