BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNC-RX SYSTEM

    MDR report key: 5909071 · Received August 26, 2016

    Report

    Report Number
    2939520-2016-00062
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Date of Event
    July 27, 2016
    Report Date
    July 27, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OWB
    PMA / PMN Number
    K132558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE IS UNDER INVESTIGATION DBR ACCORDING TO THE MANUFACTURER'S POLICY. THERE WAS NO PATIENT INVOLVEMENT AND THEREFOR NO PATIENT INFORMATION IS AVAILABLE. A REVIEW OF COMPLAINT CASES SUBMITTED FOR THIS ASSET WAS PERFORMED AND NO OTHER SIMILAR COMPLAINTS WERE REPORTED ON THIS ASSET FOR THIS FAILURE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO THE MANUFACTURER THAT A JOYSTICK INSTALLED ON THE SYSTEM HAD INTERMITTENT FUNCTIONALITY. A REPLACEMENT KIT OF LOCAL USB EXTENDER AND REMOTE USB EXTENDER (LEX/REX) WAS SENT TO THE FACILITY. THE FACILITY ENGINEER REPORTED THAT AFTER CONNECTING THE REX EXTENDER TO THE USB CAT5 CABLE THEY IMMEDIATELY SMELLED WHAT APPEARED TO BE BURNT ELECTRICAL. THE FAILED LEX/REX KIT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED LEX/REX KIT WAS INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE REPORTED BURNED SMELL AND BURN DAMAGE WAS CONFIRMED ON THE REX PCB. THE REPORTED INCIDENT DID NOT OCCUR DURING A PATIENT PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557440 SYNC-RX SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB VOLCANO CORPORATION TLA, SYNCVISION

    Patients

    Seq Age Sex Outcome Treatment
    1