BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 14845509 · Received June 28, 2022

    Report

    Report Number
    2242352-2022-00576
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 2, 2022
    Report Date
    August 16, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    MWS
    UDI-DI
    00607567700581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    #TRACKWISE (B)(6). UPDATED SECTION: B4, G4, G7, H2, H3, H6, H10 THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 06/20/2022. PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC INSPECTION WAS CONDUCTED. THE PRODUCT BOX WAS OBSERVED TO BE DENTED ON THE SIDE IN PHOTOGRAPH #2. NO OTHER VISUAL DEFECTS WERE OBSERVED IN THE PHOTOGRAPH. AN INVESTIGATION WAS CONDUCTED ON 07/20/2022. A VISUAL INSPECTION WAS CONDUCTED. THE DEVICE WAS RETURNED INSIDE THE PACKAGING MATERIAL. THE PACKAGING BOX WAS OBSERVED TO BE DENTED ON THE ONE END. AN INDENT WAS ALSO OBSERVED ON THE FRONT SIDE OF THE PACKAGING BOX. THE DEVICES INSIDE THE PACKAGING BOX WAS OBSERVED TO BE INTACT, WITH NO VISUAL DEFECTS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "SHIPPING DAMAGE OR PROBLEM" WAS CONFIRMED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL/LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE LOT HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE

    Description of Event or Problem · 0

    SSU GETINGE GROUP TAIWAN CO., LTD. REPORTED A DAMAGED SHIPMENT. THEY RECEIVED THE SHIPMENT ON JUNE 02, AND THE OUTSIDE BOX WAS IN FINE CONDITION. BUT THEY FOUND ONE BOX WITH A HOLE. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017136 ACROBAT-I STABILIZER STABILIZER, HEART MWS MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER 25162834 00607567700581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown