BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT RF GENERATOR

    MDR report key: 1033842 · Received April 24, 2008

    Report

    Report Number
    9612355-2008-00007
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER (BWI) TECHNICAL SVCS EVALUATED THE STOCKERT GENERATOR AND DID NOT FIND ANY TEMP ISSUE. THE BWI TECHNICAL SVCS ALSO PERFORMED A FUNCTIONAL AND SAFETY TEST ON THE STOCKERT GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO ABLATE USING THE STOCKERT RF GENERATOR, AN ERROR MESSAGE INDICATING "TEMP TOO LOW" WAS DISPLAYED. PER CUSTOMER, THE PT CODED WHILE THE STAFF ATTEMPTED TROUBLESHOOTING FOR THE ERROR MESSAGE. IT WAS ALSO REPORTED THAT THE PT SURVIVED THE CODE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening