BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 9156801 · Received October 4, 2019

    Report

    Report Number
    2242352-2019-01097
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 11, 2019
    Report Date
    December 23, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQO
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: PREMARKET IDENTIFICATION, TYPE OF REPORT, FOLLOW UP TYPE, ADVERSE EVENT PROBLEM, CONCOMITANT MEDICAL PRODUCTS. TRACKWISE # (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY S/N (B)(4) WAS NOT OUTPUTTING, IT WOULD NOT POWER THE HANDPIECE. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID #(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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY S/N (B)(4) WAS NOT OUTPUTTING, IT WOULD NOT POWER THE HANDPIECE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952341 T.W. POWER SUPPLY UNIT, CAUTERY, THERMAL, AC-POWERED HQO MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY

    Patients

    Seq Age Sex Outcome Treatment
    1