BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS CRITICAL CSRE MONITOR

    MDR report key: 336052 · Received May 31, 2001

    Report

    Report Number
    MW1022059
    Event Type
    Malfunction
    Date Received
    May 31, 2001
    Date of Event
    May 7, 2001
    Report Date
    May 29, 2001
    Manufacturer
    BAXTER HEALTHCARE, INC
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN THE EVENING IN THE INTENSIVE CARE UNIT, AN EDWARD CRITICAL CARE MONITOR SUDDENLY IMPLODED IN A PT'S ROOM. THE MONITOR BEGAN EMITTING A WHITE SMOKE AND AN UNUAL ODOR WAS REPORTEDLY PRESENT IN THE ROOM. THE MONITOR WAS IMMEDIATELY UNPLUGGED AND THE PT WAS MOVED TO A SAFE ENVIRONMENT. THE ROOM AND DEVICE WERE SECURED FROM ACCESS. THE PT WAS MONITORED FOR ANY ADVERSE EFFECTS OF THE EVENT AND FOUND TO HAVE NO COMPLAINTS OR CHANGE IN CONDITION AS A RESULT OF THE EVENT AND FOUND TO HAVE NO COMPLAINT OR CHANGE IN CONDITION AS A REULT OF THE EVENT (THE PT WAS ON MECHANICAL VENTILATION, SOMEWHAT PROTECTING THEM FROM ROOM AIR). A PLANT OPERATIONS TECHNICIAN WAS IMMEDIATELY DISPATCHED AND ARRIVED TO THE UNIT SHORTLY AFTER NOTIFICATION. APPROXIMATELY ONE HR POST EVENT THE EMPLOYEE WHO WAS PRESENT AT THE TIME OF THE EVENT BEGAN COUGHING AND FEELING NAUSEATED. EMPLOYEE COMPLAINED OF A METALLIC TASTE IN THEIR MOUTH AND A HEADACHE. EMPLOYEE WAS ASSESSED IN THE EMERGENCY DEPT (ED) APPROXIMATELY TWO HRS POST EVENT. POISON CONTROL WAS NOTIFIED AND A DIAGNOSIS OF "METAL FUME FEVER" WAS ESTABLISHED. THE EMPLOYEE WAS ADVISED TO RETURN TO THE ED IF SYPTOMS BECAME WORSE. BIOMED ASSESSED THE MONITOR AND FOUND THAT AN ELECTROLYTIC CAPACITOR HAD FAILED. THE EMPLOYEE'S SYMPTOMS SUBSIDED WITHIN A WEEK AND THEY RETURNED TO WORK WITHOUT RESTRICTIONS. AN IRRITANT LEVEL EXPOSURE WAS ESTABLISHED. THE PT CONTINUED HAVE NO ADVERSE EFFECTS FROM THE EVENT AND WAS EVENTUALLY DISCHARGED WITHOUT NEGATIVE SEQUELAE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 09/17/01: THE MONITOR DISPLAYED ONLY A SINGLE HORIZONTAL LINE IN THE CENTER OF THE SCREEN AND THAT THE MONITOR SMOKED, CAUSING A NURSE TO BE OVERCOME BY FUMES. THE NURSE WAS TAKEN TO THE ER COMPLAINING OF A HEADACHE AND NAUSEA. THE NURSE WAS GIVEN TYLENOL AND RELEASED. NURSE WAS FINE. POISON CONTROL WAS CONTACTED AND IT WAS DETERMINED THAT THE NURSE WAS OVERCOME BY METAL FUMES. THE PT WAS UNAFFECTED BY THE INCIDENT. MFR'S EVALUATION PROCESS WAS AS FOLLOWS: UPON RETURN TO EDWARDS, UNIT WAS POWERED UP. CRT (DISPLAY) WAS NOT ON. HORIZONTAL LINE WAS OBSERVED ACROSS DISPLAY FIELD. TOP COVER OF VIGILANCE WAS OPENED. A BURNT ODOR WAS OBSERVED. UPON VISUAL EXAMINATION, RED CAN CAPACITOR ON THE VIDEO CONTROL BOARD WAS OBSERVED TO BE BLOWN OPEN. VIDEO CONTROL BOARD WAS REPLACED. UNIT WAS POWERED ON AND CRT APPEARED TO BE FUNCTIONING NORMALLY. THE MECHANISM INVOLVED IN THE FAILURE IS THE 50V RED CAN CAPACITOR ON THE VIDEO CONTROL BOARD. BASED ON MFR'S EXPERIENCE, THIS COMPONENT CAN WEAR OVER TIME. IF THIS EVENT OCCURS, THE READINGS ON THE MONITOR WILL NO LONGER BE DISPLAYED. A REVIEW OF MFR'S COMPLAINT DATABASE DID NOT REVEAL ANY REPORTS OF PERMANENT PT OR USER INJURY AS A RESULT OF THIS TYPE OF EVENT. IN THIS CASE, THERE WAS NO REPORT OF MEDICAL INTERVENTION OR COMPLICATIONS FOR THE USER OR PT. IT HAS BEEN DETERMINED BY MFR'S ELECTRONIC SERVICE CENTER THAT THE MEDICAL DEVICE REPORT IS ATTRIBUTABLE TO THE DEVICE. AFTER THE DEVICE WAS EVALUATED, REPAIRED AND FUNCTIONALLY TESTED, THE UNIT WAS SHIPPED TO ANOTHER ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25079 EDWARDS CRITICAL CSRE MONITOR CARDIAC OUTPUT MONITOR MHX BAXTER HEALTHCARE, INC VGS *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other