BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUKUDA DENSHI

    MDR report key: 2722895 · Received August 24, 2012

    Report

    Report Number
    9611031-2012-00002
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    May 28, 2010
    Report Date
    August 24, 2012
    Manufacturer
    FUKUDA DENSHI CO, LTD
    Product Code
    DSI
    PMA / PMN Number
    K964187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS BEING ISSUED AS RESULT OF CHANGES TO COMPANY SOP'S AND DEFINITIONS OF MDR. THIS REPORTABLE EVENT WAS FOUND DURING FDA INSPECTION AND SUBSEQUENT REVIEW OF CRITICAL COMPLAINTS. IT WAS DETERMINED THAT THIS EVENT OCCURRED AS A RESULT OF A MALFUNCTION TO THE DEVICE POSSIBLY CAUSED BY USER ERROR (DROPPING THE DEVICE AND CRACKING THE CASE. THIS MDR IS BEING PROVIDED AS REQUESTED FROM THE WARNING LETTER ISSUED BY FDA AND AS INDICATED WILL DO IN COMPANY RESPONSE TO FDA RE: CMS CASE # (B)(4). FUKUDA DENSHI COMPLAINT NO. (B)(4) WAS AS THE RESULT OF AN END-USER AT (B)(6) HOSPITAL ON (B)(6) 2010 COMPLAINING OF A BURNING SMELL COMING OUT OF A CARDIAC OUT-PUT MODULE (HF-500) WHICH WAS ATTACHED TO A PT MONITOR FUKUDA DENSHI MODEL DS-5300. AS A RESULT OF THIS COMPLAINT, FUKUDA DENSHI PERFORMED A FULL INVESTIGATION AND ISSUED "HF-500 DETAILED REPORT OF FAILURE INVESTIGATION" DATED (B)(6) 2010. A MEDICAL DEVICES SAFETY INFORMATION REPORT WAS FILED BY THE USER WITH (B)(6) ON (B)(6) 2010 USING DOCUMENT NO. (B)(4), SENT TO FUKUDA DENSHI ON (B)(6) 2010. FUKUDA DENSHI THEN RESPONDED TO THE FILED REPORT WITH THE RESPONSE DATED (B)(6) 2010 BACK TO THE (B)(6). IT WAS DETERMINED THAT THIS INCIDENT OCCURRED AS A RESULT OF A BURNED VARISTOR. IT WAS ALSO OBSERVED THAT THE DEVICE CASE HAD CRACKED PERHAPS DUE TO AN EARLIER DROP AND THAT THIS DEVICE HAD BEEN IN USE FOR 12 YEARS AND 3 MONTHS. IT WAS DETERMINED THAT THE VARISTOR COULD HAVE BEEN DAMAGED DUE TO THE IMPACT THAT RESULTED IN THE CRACKED CASE. IN FURTHER INVESTIGATION, IT WAS DETERMINED THAT AT THE TIME FUKUDA DENSHI HAD AN ALREADY INSTALLED BASED OF 1226 UNITS AND THIS WAS THE FIRST CASE SEEN FOR THIS TYPE OF FAILURE OF THE VARISTOR. FUKUDA DENSHI VISITED THE CUSTOMER AND PROVIDED A THOROUGH EXPLANATION OF THE DEVICE MALFUNCTION, EXPLAINED THE CONSEQUENCES OF OPERATING A DEVICE AFTER AN APPARENT FALL AND SUBSEQUENT CRACKED CASE AND MADE THE DECISION TO REPLACED THE MONITORING SYSTEM. ADDITIONALLY, COMPLETE DOCUMENTATION AND CORRESPONDENCE WAS FORWARDED TO THE FDA IN THE FUKUDA DENSHI FDA 2ND RESPONSE LETTER DATED 06/14/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI PATIENT MONITOR - CARDIAC OUTPUT MODULE DSI FUKUDA DENSHI CO, LTD HF-500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK