BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 2891401 · Received December 26, 2012

    Report

    Report Number
    2242352-2012-01353
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY WHICH WOULD BE CONSIDERED RELATED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I STABILIZER WAS STICKING AT THE ARM SWIVEL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT-I STABILIZER CLAMPLESS BEATING HEART GEI MAQUET CARDIOVASCULAR, LLC OM-10000 25065868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA