BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO POWER SUPPLY

    MDR report key: 16685004 · Received April 5, 2023

    Report

    Report Number
    2242352-2023-00277
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 24, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQO
    UDI-DI
    00607567700826
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID 790755. 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.

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE SERIAL # (B)(6). THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT PRIOR TO AN ENDOSCOPIC VEIN HARVESTING PROCEDURE IT WAS DISCOVERED THAT THE T.W. POWER SUPPLY S/N H10030133G HAND PIECE HAD NO POWER. WARRANTY EXPIRED (B)(6) 2013. THEY USED ANOTHER VH-3010 TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242512 HEMOPRO POWER SUPPLY UNIT, CAUTERY, THERMAL, AC-POWERED HQO MAQUET CARDIOVASCULAR LLC VH-3010 00607567700826

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown