BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8900264 · Received August 16, 2019

    Report

    Report Number
    2242352-2019-00954
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 15, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT/SERIAL HISTORY REVIEW WAS NOT APPLICABLE. A LOT/SERIAL NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT LOT/SERIAL NUMBER CANNOT BE IDENTIFIED FROM A SHIP HISTORY, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 ADAPTOR, THEY PERFORMED THE SELF TEST WITH NO POWER. THEY SWITCHED OUT THE STERILIZED CORD WITH NO HELP. THEY THEN TRIED TO CHANGE OUT THE POWER SUPPLY WITH NO HELP. THEY THEN CHANGED OUT THE VH-4020 AND IT WORKED. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    TRACKWISE : (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 ADAPTOR, THEY PERFORMED THE SELF TEST WITH NO POWER. THEY SWITCHED OUT THE STERILIZED CORD WITH NO HELP. THEY THEN TRIED TO CHANGE OUT THE POWER SUPPLY WITH NO HELP. THEY THEN CHANGED OUT THE VH-4020 AND IT WORKED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693846 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC HEMOPRO2 ADAPTOR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1