BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE MEDICAL

    MDR report key: 951167 · Received November 16, 2007

    Report

    Report Number
    MW5004467
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    November 16, 2007
    Report Date
    November 16, 2007
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I RECENTLY PURCHASED AN ANEROID SPHYGMOMANOMETER - PRESTIGE MEDICAL - MODEL 82. THE PRODUCT IS SAID TO COME FULLY CALIBRATED AND HAVE A LIFETIME CALIBRATION WARRANTY. UPON RECEIPT OF THE PRODUCT I NOTED THAT TURNING AT THE TUBING IN THE AREA WHERE IT LEADS INTO THE MANOMETER CAUSES THE NEEDLE TO MOVE FORWARD OR BACKWARDS ALONG THE DIAL. IF YOU TURN THE TUBING IN A PURPOSEFUL MANNER THE NEEDLE WILL MOVE WELL BEYOND THE 20 MM-HG LEVEL CLOCKWISE AND WELL PAST THE 300 MM-HG LEVEL COUNTERCLOCKWISE. THIS DEFECT APPEARS AS IF IT COULD SIGNIFICANTLY ALTER THE READINGS OF THE DEVICE. I AM CONCERNED ABOUT THIS PROBLEM AS IT APPEARS THAT IT MAY BE THE RESULT OF FAULTY OR FRAUDULENT MANUFACTURING. AN UNSUSPECTING CLINICIAN COULD EASILY PICK UP THIS DEVICE AND USE IT WHEN THE DEVICE IS ASSEMBLED AND NOT NOTICE THIS DEFECT. I AM CONCERNED AS I HAVE NEVER SEEN A MANOMETER THAT ACTED IN THIS MANNER AND NO MANOMETER THAT I CHECKED APPEARS TO ACT IN THIS MANNER. THE DEVICE WAS PURCHASED. THE DEVICE WAS SHIPPED. THE DEFECT WAS FOUND UPON MY INSPECTION OF THE PRODUCT AND THE DEVICE THAT I REC'D WAS NEVER USED IN CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE MEDICAL ANEROID SPHYGMOMANOMETER DXQ 82

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability