BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL TRANSDUCER

    MDR report key: 902773 · Received August 24, 2007

    Report

    Report Number
    1526863-2007-00025
    Event Type
    Malfunction
    Date Received
    August 24, 2007
    Report Date
    August 1, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER IS UNK. THE TWO POSSIBLE LOTS ARE 36K29E0801 (EXP DATE 11/2009) OR 36L01E0901 (EXP DATE 12/2009). THE MANUFACTURER DATES FOR THE POSSIBLE LOT NUMBERS ARE 36K29E0801, 11/2006 AND 36L01E0901, 12/2006. THE SUBASSEMBLY IN QUESTION IS A960 AND IS MANUFACTURED BY SMITHS MEDICAL ASD. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PRODUCT (MX960) BY SMITHS MEDICAL INTERNATIONAL. THE FINISHED PRODUCT IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL INTERNATIONAL. BOTH THE RETURNED TRANSDUCER AND THE MATING CABLE WERE TESTED AND MET ALL SPECIFICATIONS. NO DEFECTS WERE NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBASSEMBLY WITH NO ISSUES PRESENT. REVIEW OF THE COMPLAINT DATABASE INDICATES THIS IS THE THIRD REPORTED ERRONEOUS READING ISSUE INVOLVING THIS SUBASSEMBLY IN THE LAST 24 MONTHS. ONE INVOLVED WEAR AND INCORRECT CLEANING METHODS. ONE WAS DUE OT A DAMAGED GEL CUP. SMITHS WAS UNABLE TO CONFIRM THE ISSUE. THE DEVICE FUNCTIONED CORRECTLY. NO ADDITIONAL ACTION NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER REPORTED TO SMITHS MEDICAL THAT DRUGS WERE ADVISED AND INAPPROPRIATELY ADMINISTERED DUE TO A FAULTY PRESSURE TRANSDUCER. DURING AN OPERATION, THE PATIENT APPEARED TO HAVE A MASSIVE HYPERTENSIVE RESPONSE TO CRANIOTOMY. THE BLOOD PRESSURE REMAINED AT 210/150 VIA THE ARTERIAL LINE DESPITE A HIGH DOSE OF DRUGS. THE ARTERIAL LINE READING WAS THEN CHECKED AGAINST A NON INVASIVE BLOOD PRESSURE, WHICH WAS FOUND TO BE 87/52. THE ARTERIAL LINE PRESSURE THEN READ 80/50. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL TRANSDUCER REUSABLE PRESSURE TRANSDUCER DRS SMITHS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR