BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1222895-2015-00029

    MDR report key: 4905142 · Received July 8, 2015

    Report

    Report Number
    1222895-2015-00029
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 12, 2015
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9/9/15 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION FAILURE ANALYSIS - THE SINGLE BAY CHARGER WAS RETURNED, NOT 60W POWER SUPPLY. SINGLE BAY CHARGER POWER ON WITHOUT A FIRE OR SMOKE OF ANY KIND. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER / MANUFACTURING CHANGE ORDER HISTORY: NONE RELATED. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE RELATED. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: IT APPEARS THE MOST LIKELY SCENARIO IS THAT THE CHARGE CONTROLLER IC, U4 FAILED INTERNALLY, TURNING Q3 ON, CONNECTING 24V TO Q4A DRAIN. Q4A TURNED ON LINEARLY, OVERHEATING, WHICH CAUSED A GATE TO DRAIN SHORT, SHORTING THE 24VDC TO GROUND THRU U4-3. OUR CHARGERS HAVE BEEN TESTED TO AND PASSED CE LEVEL IV ESD, 15,000V, ON ALL CONNECTORS SO EOS/ESD WAS NOT THE CAUSE OF THE FAILURE.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS NO PATIENT INJURY. POWER SUPPLY PLUGGED IN AND CAUGHT FIRE. ON (B)(6) 2015 CUSTOMER REPORTS "NO SURGERY PLANNED. WE JUST RECEIVED NEW POWER SUPPLY (407481) FOR THE BATTERY BAY (90523) AND MANAGER PLUGGED THE POWER SUPPLY INTO ITS BAY. PLUGGED INTO WALL AND FIRE CAUGHT INSIDE THE BATTERY BAY. FIRE STARTED A SECOND AFTER I PLUGGED IT IN." NO HARM DONE, NO PATIENT INVOLVEMENT. EVENT TOOK PLACE IN CLINIC DEPARTMENT, NOT IN THE OPERATION ROOM. 2 OF 2 RELATED COMPLAINT.

    Patients

    Seq Age Sex Outcome Treatment
    1