BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINTENANCE STATION

    MDR report key: 3003620 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10446
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE HOSPITAL PURCHASED E-PEN MAINTENANCE STATION IN (B)(6) 2010 AND HAD NOT TAKEN DEVICE OUT OF THE BOX UNTIL (B)(6) 2011. WHEN HOSPITAL TRIED TO USE THE STATION ALL COMPONENTS WORKED EXCEPT THE POWER CORD. THE POWER CORD DID NOT GENERATE ANY POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86985 MAINTENANCE STATION ERL, HBE, HWE DZI SYNTHES GMBH 961

    Patients

    Seq Age Sex Outcome Treatment
    1