BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGICAL SINGLE KIT

    MDR report key: 2122967 · Received June 9, 2011

    Report

    Report Number
    2183502-2011-00477
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SMITHS MEDICAL INTL., LTD.
    Product Code
    DRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PT. WHEN COMPARING THE BLOOD PRESSURE RESULTS FROM THE PRODUCT LISTED WITH A NON-INVASIVE PRESSURE READING, THE VALUES DIFFERED (NON-INVASIVE PRESSURE READING WAS LOWER). HOWEVER, BLOOD PRESSURE MEDICATION HAD ALREADY BEEN ADMINISTERED IN RESPONSE TO THE BLOOD PRESSURE RESULTS GIVEN FROM THE PRODUCT LISTED. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL SINGLE KIT PRESSURE MONITORING SET DRS SMITHS MEDICAL INTL., LTD. NA 1950324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention