BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED PULSAR I GENERATOR

    MDR report key: 5390231 · Received January 26, 2016

    Report

    Report Number
    1226420-2016-00011
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Date of Event
    December 8, 2015
    Report Date
    January 8, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS (B)(4): EVALUATION PROCESS: PERFORMED VISUAL INSPECTION IAW (B)(4): -SCRAPES AND GOUGES ON UPPER AND LOWER CASES. -LARGE SCRATCH ON LEFT SIDE OF FRONT PANEL OVERLAY PERFORMED BASELINE PERFORMANCE TESTING IAW (B)(4): -NO ISSUE NOTED -THE PHYSICAL DAMAGE IDENTIFIED HAD NO IMPACT TO FUNCTIONALITY OF THE UNIT. -ERROR LOG INDICATES THAT THE UCB REAL TIME CLOCK BATTERY DIED ON OR AFTER (B)(4) 2014 DURING PERFORMANCE OF ELECTRICAL SAFETY HI-POT TESTING IAW (B)(4), THE CONDOR POWER SUPPLY FAILED (ARCING WAS DETECTED). SUBSEQUENT ATTEMPTS TO POWER UNIT ON FAILED AS THE 24VDC OUTPUT OF THE CONDOR POWER SUPPLY WAS UNAVAILABLE. REPLACEMENT OF POWER SUPPLY RESTORED SYSTEM FUNCTIONALITY. ROOT CAUSE: -NO PERFORMANCE ISSUES NOTED. -THE PHYSICAL DAMAGE IS CONSISTENT WITH ROUGH HANDLING IN THE FIELD. -THE CASE STAINING IS DUE TO THE USE OF AGGRESSIVE CLEANING AGENTS IN THE FIELD AND DOES NOT AFFECT SYSTEM PERFORMANCE. -THE UCB REAL-TIME CLOCK BATTERY DIED DUE TO AGE. THE DEAD BATTERY RESULTS IN A RESETTING OF THE SYSTEM CLOCK TO 12:00AM (B)(4) 2013 WHICH RESULTS IN INACCURATE TIME STAMPING OF ATTACHED DEVICES AND PREVENTS DETECTION OF EXPIRED DEVICES. THE CONDOR FAILED INTERNALLY (ARCING) DURING APPLICATION OF 4000VAC TO THE MONOPOLAR CONNECTOR. (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED AS CUSTOMER CONTACT REFUSED TO PROVIDE REQUESTED INFORMATION.

    Description of Event or Problem · 1

    GENERATOR RETURNED AS A NON-COMPLAINT BUT DURING SERVICING IT WAS DISCOVERED AND REPORTED THAT DURING ELECTRICAL SAFETY TESTING ARCING WAS DETECTED AND THE POWER SUPPLY FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50162 REFURBISHED PULSAR I GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF

    Patients

    Seq Age Sex Outcome Treatment
    1