BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 2182498 · Received July 11, 2011

    Report

    Report Number
    2242352-2011-00913
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED NO NON CONFORMITIES WITH THE RETURNED UNIT. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. A FUNCTIONAL TEST WAS CONDUCTED TO DETERMINE IF THERE IS A MECHANICAL FAILURE WITH THE KNOB. THE KNOB WAS TIGHTENED TO LOCK THE FLEX LINK ARM IN PLACE. NO NON-CONFORMITIES WERE FOUND DURING THE FUNCTIONAL TESTING. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT "KNOB JUST KEPT SPINNING" 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE OM-10000 HOOKED ON THE RETRACTOR FINE, BUT WHEN THEY TRIED TO TIGHTEN IT UP, THE KNOB JUST KEPT SPINNING. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT-I STABILIZER ACROBAT-I STABILIZER MWS MAQUET CARDIOVASCULAR, LLC. OM-10000 25034706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA