BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 4143696 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-01196
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE CONTROL UNIT IS NOT FUNCTIONING. THIS IS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE DID NOT WORK. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624624 EPD 60000 RPM HWE SYNTHES GMBH 3174

    Patients

    Seq Age Sex Outcome Treatment
    1