BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAUMANOMETER

    MDR report key: 393589 · Received May 9, 2002

    Report

    Report Number
    393589
    Event Type
    Other
    Date Received
    May 9, 2002
    Date of Event
    January 31, 2002
    Report Date
    April 1, 2002
    Manufacturer
    W.A. BAUM CO, INC
    Product Code
    DXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BLOOD PRESSURE UNIT BLEW, CAUSING 2.5 OUNCES OF MERCURY TO VAPORIZE. DUE TO THE REMOVAL OF THIS UNIT AND ALL SIMILAR UNITS THE MODEL # IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 07/12/02: WE RECEIVED REPORT NUMBER 8140400000-2002-0001. FROM A PHONE INTERVIEW WITH THE REPORTER OF THE EVENT, IT WAS DETERMINED THAT IT WAS POSSIBLE THAT THE APPROX 8 YEAR OLD INSTRUMENT MAY WELL HAVE BEEN KNOCKED OVER PRIOR TO USE, AND THAT THE OLD STYLE GLASS TUBE MAY HAVE BEEN CRACKED WITHOUT IT HAVING BEEN NOTICED, UNTIL IT WAS USED THE NEXT TIME, WHEN IT LEAKED. IT WAS THEN DISCARDED, AND COULD NOT BE INSPECTED. 4. THE FINAL RESULTS OF FAILURE ANALYSIS. THE INSTRUMENT HAD NOT BEEN RETURNED TO MFR. NO OTHER SUCH REPORTS HAVE BEEN MADE TO MFR. MFR BELIEVES THAT THE INSTRUMENT WAS PROBABLY OLDER THAN 8 YEARS, AND DID NOT HAVE A MYLAR CLAD GLASS CARTRIDGE TUBE INSTALLED. 5. EVALUATION OF OTHER INFO BY FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED ARE ATTRIBUTE TO THE DEVICE, OR NOT. THROUGH PHONE INTERVIEWS WITH THE REPORTER, MFR BECAME RESONABLY CONFIDENT THAT THE DEVICE MUST HAVE SUFFERED A PHYSICAL SHOCK WHICH BROKE THE GLASS TUBE PRIOR TO IT HAVING BEEN USED. THE INSTRUMENTS ARE TESTED AT A PRESSURE TWICE THE RANGE OF THE SCALE, WHEN MANUFACTURED. A REVIEW OF COMPLAINT FILES SHOW NOT TREND OR SIMILAR REPORTS. 6. THE DATE THE EVENT DESCRIBED OCCURRED, JANURARY 31, 2001. 7. THE DATE FIRM RECEIVED INFO ABOUT THE EVENT APRIL 24, 2002. 8. THE DEIVCE WAS NOT, AND WILL NOT BE RETURNED TO MFR, IT WAS THROWN AWAY. THE ORIGINAL REPORT CLAIMED THAT THE MERCURY "VAPORIZED". THE INSTRUMENT WAS USED AT ROOM TEMPERATURE. DENTAL GRADE MERCURY, THE KIND FOUND IN THIS INSTRUMENT, HAS A BOILING POINT OF 674 DEGREES F. IT COULD NOT VAPORIZE. APPROX 8 YEARS AGO THE GLASS TUBES, IN WHICH THE MERCURY RISES AND FALLS, WERE FITTED WITH A TRIPLE LAYER OF MYLAR TO STRENGTHEN THE TUBES WHILE KEEPING THEN INTACT, SHOULD THEY BE FORCIBLY BROKEN. IF THE INSTRUMENT HAD BEEN FITTED WITH A MYLAR CLAD TUBE, IT IS HIGHLY IMPROBABLE THAT IT WOULD HAVE LEAKED MERCURY, EVEN IF THE GLASS TUBE HAD BEEN BROKEN, PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAUMANOMETER STAND-BY B/P MACHINE DXN W.A. BAUM CO, INC UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other