BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPOSE 4 DEVICE

    MDR report key: 2152436 · Received June 24, 2011

    Report

    Report Number
    2242352-2011-00680
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 30, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED NO NON CONFORMITIES WITH THE RETURNED DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE UNIT. A FUNCTIONAL TEST WAS PERFORMED TO DETERMINE IF THE XPOSE WOULD TIGHTEN OR NOT. THE XPOSE AND THE FLEX LINK ARM WERE SECURED IN PLACE WHEN THE KNOB WAS TIGHTENED. BASED UPON THE FINDINGS ABOVE, THE REPORTED COMPLAINT "WOULD NOT LOCK INTO POSITION" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE XPOSE 4 DEVICE WOULD NOT LOCK INTO POSITION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPOSE 4 DEVICE XPOSE 4 DXC MAQUET CARDIOVASCULAR, LLC XP-4000 25026761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA