BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC EXTENSION CABLE

    MDR report key: 3832332 · Received February 10, 2014

    Report

    Report Number
    2242352-2014-00067
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 15, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR SOPS, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO WOULD NOT WORK. THEY SWITCHED OUT THE DC EXTENSION CABLE AND THE DEVICE WORKED FINE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87905 DC EXTENSION CABLE ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC VH-3030 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI