BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNTECH

    MDR report key: 3024748 · Received March 27, 2013

    Report

    Report Number
    3024748
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SUNTECH MEDICAL
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SUNTECH CUFFS (FOR PEDIATRIC PATIENTS) ARE MADE OF A STIFF MATERIAL THAT DOESN'T ALLOW FOR AN ACCURATE BP READING. WE'VE HAD SEVERAL INSTANCES IN THE OR WHERE THE PATIENT'S BLOOD PRESSURE WAS READ AS HYPERTENSIVE WHEN IT WAS, IN FACT, NORMAL. THERE EXISTS THE POTENTIAL TO HARM A PATIENT BY TREATING THE HYPERTENSIVE BLOOD PRESSURE, OR NOT TREATING A HYPOTENSIVE PATIENT WHEN THE READING IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127220 SUNTECH BLOOD PRESSURE CUFF DXN SUNTECH MEDICAL CHILD 12-19 CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *