BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL KIT

    MDR report key: 1003233 · Received February 21, 2008

    Report

    Report Number
    1526863-2008-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER WAS UNSURE IF THE PRODUCT WAS MX9625 (LOT 1158154) OR MX9622 (LOT 1206516 OR LOT 1176659). MX9265,- LOT 1158154 EXP DATE 05/2012, MFG DATE 05/2007. MX9622 LOT 1176659, EXP DATE 06/2012, MFG DATE 06/2007. THE SUBASSEMBLY IN QUESTION IS A560 (A333R-70) AND IS MANUFACTURED BY SMITHS MEDICAL. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PRODUCT (MX9622 & MX9625) BY SMITHS MEDICAL INT'L. THE FINISHED PRODUCT IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL INT'L. THE CUSTOMER INDICATED THAT THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY WAS REVIEWED FOR THE ABOVE LOTS WITH NO RELATED ISSUES FOUND. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT BENEFIT OF RETURNED PRODUCT EVAL. THIS ISSUE IS BEING MONITORED. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    FOREIGN HOSPITAL REPORTED TO SMITHS MEDICAL, THAT THE TUBING BECAME DISCONNECTED AT THE PT END, WHERE IT SHOULD HAVE BEEN SOLVENTED. THERE WAS NO PT INJURY OR TREATMENT REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL KIT PRESSURE MONITORING SET DRS SMITHS MEDICAL MX9622 1206516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK