BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 3222672 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04293
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE RESULTS OF THE MANUFACTURING EVALUATION ARE AS FOLLOWS: THE COMPLAINED COLIBRI WAS FORWARDED TO OUR SERVICE DEPARTMENT FOR INVESTIGATION. THE INVESTIGATION OF THE COMPLAINT ARTICLE HAD SHOWN THAT THE MACHINE IS ALWAYS RUNNING EVEN WITHOUT OPERATING THE SPEED BUTTON. THE CONTROL SYSTEM OF THE MACHINE WAS DEFECTIVE AND HAD SOME FAILURE. THE OVERDUE SERVICE WAS DONE AND THE REPAIRED DEVICE WAS SEND BACK TO THE CUSTOMER. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED ON AN UNKNOWN DATE, THAT THE COLIBRI DEVICE ALWAYS RUNS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321726 COLIBRI HWE SYNTHES GMBH SER. NO. 10374

    Patients

    Seq Age Sex Outcome Treatment
    1