BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL CARTRIDGE W/ 2 STOPCOCKS

    MDR report key: 1203293 · Received October 14, 2008

    Report

    Report Number
    9616567-2008-00101
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Report Date
    September 19, 2008
    Manufacturer
    SMITHS MEDICAL, ASD
    Product Code
    DRS
    PMA / PMN Number
    K820355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT SAMPLES WERE AVAILABLE; HOWEVER, NO SAMPLES HAVE BEEN RECEIVED. SMITHS IS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT RETURNED PRODUCT EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD INFO BECOME AVAILABLE THAT IMPACTS SMITHS' INVESTIGATION. ADDITIONAL LOT NUMBER: 1274953.

    Description of Event or Problem · 1

    THE REPORTER STATED DURING MONITORING OF ARTERIAL BLOOD PRESSURE, AN UNEXPLAINED PRESSURE DISPLAY CHANGE OCCURRED. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL CARTRIDGE W/ 2 STOPCOCKS PRESSURE MONITORING SET DRS SMITHS MEDICAL, ASD NA 1271210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK