BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3811833 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05055
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF"ALARM SOUNDS THEN CONSOLE SHUTS OFF" WAS NOT CONFIRMED. RELIABILITY ENGINEERING WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HOWEVER, THE UNIT DID EXHIBIT SOME PHYSICAL DAMAGE THAT IS CONSISTENT WITH THE UNIT HAVING BEEN DROPPED. THE CHASSIS OF THE UNIT HAD BEEN BENT, AND PORT 1 WAS OUT OF ALIGNMENT. THIS CONDITION IS INDICATIVE OF IMPROPER HANDLING OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT WHEN THE DEVICE WAS PLUGGED IN, AN ALARM SOUNDED AND THE CONSOLE IMMEDIATELY SHUT OFF. THE DEVICE WAS BEING USED DURING SURGERY, BUT THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF ANY MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524598 SYSTEM CONSOLE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1