BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITAIRE

    MDR report key: 1579042 · Received December 22, 2009

    Report

    Report Number
    2510954-2009-00005
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    January 6, 2009
    Report Date
    December 22, 2009
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    K003335
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP CALL WAS MADE TO THE FACILITY FOR MORE INFO PERTAINING TO THE EVENT. THE BIOMED ADVISED THAT THE UNIT DISPLAYED "ERROR 5" AND WAS MOVED TO THE BIOMED SHOP FOR SERVICING. THE HEATER ELEMENT WAS REPLACED BY ANOTHER PERSON IN THE SHOP; HOWEVER, WHEN THE UNIT WAS POWERED ON IT STILL DISPLAYED "ERROR 5." A CALL WAS MADE TO DRAEGER TECHNICAL SUPPORT FOR HELP IN TROUBLESHOOTING THE PROBLEM. TECHNICAL SUPPORT ASKED THE BIOMED TO RUN THE DIAGNOSTIC TESTS AND WHEN OFF-LINE DIAGNOSTICS TEST #6 WAS SELECTED; SMOKE, FLAMES AND SPARKS STARTED SHOOTING FROM THE SIDE OF THE CONTROLLER. IT SHOULD BE NOTED THAT OFF-LINE DIAGNOSTICS TEST MODE IS A SERVICE MODE AND NOT A MODE USED DURING CLINICAL USE. A REPLACEMENT CONTROLLER, HEATER, AND CABLE ASSEMBLY WAS SENT TO THE CUSTOMER AND THE BIOMED WAS ASKED TO RETURN THE FAILED PARTS FOR EVAL. THE SUBJECT CONTROLLER WAS RECEIVED FOR EVAL AND UPON DISASSEMBLY OF THE CONTROLLER IT WAS CONFIRMED THAT THIS WAS THE ORIGINAL BOARD WHICH WAS PRODUCED IN 06/1999 AND THE DAMAGE WAS FOUND TO BE ISOLATED TO THE POWER BOARD IN THE AREA OF THE RELAYS. THE SOLID STATE RELAYS AND SAFETY RELAY WERE REMOVED FROM THE BOARD AND INDIVIDUALLY TESTED. THE SOLID STATE RELAYS AND SAFETY RELAY WERE FOUND TO BE OPERATIONAL. FURTHER INVESTIGATION REVEALED THE FAILURE WAS ISOLATED TO THE AC HOT SIGNAL POWER BOARD TRACE FROM CONNECTOR J6 TO THE SAFETY RELAY K1 PINS 6 AND 7. THE FAILURE WAS CAUSED BY HIGH CONTACT RESISTANCE BETWEEN THE PLATED THRU HOLE AND THE TRACE. THE HIGH CONTACT RESISTANCE WAS CAUSED BY DEGRADATION OF THE PLATED THRU HOLE OVER TIME.

    Description of Event or Problem · 1

    THE RESUSCITARE CAME INTO THE BIOMED SHOP BECAUSE THE CONTROLLER DISPLAYED ERROR 5 AT STARTUP. THE HEATING ELEMENT WAS REPLACED AND UPON POWER UP OF THE UNIT, ERROR 5 WAS DISPLAYED AGAIN ON THE CONTROLLER. OFF-LINE DIAGNOSTICS TEST MODE WAS SELECTED, WHICH IS A MODE USED FOR SERVICING. WHEN OFF-LINE DIAGNOSTICS TEST #6 WAS SELECTED; SMOKE, FLAMES AND SPARKS STARTED SHOOTING FROM THE CONTROLLER. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE INFANT RADIANT WARMER FMT DRAGER MEDICAL SYSTEMS, INC. (PNC) RW82 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA