BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 12363358 · Received August 24, 2021

    Report

    Report Number
    2242352-2021-00694
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    August 4, 2021
    Report Date
    August 31, 2021
    Product Code
    HQQ
    UDI-DI
    00607567700826
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). ANALYSIS OF PRODUCTION: (3331/213/67) THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE REPORTED SERIAL NUMBER. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH. HISTORICAL DATA ANALYSIS: (4109/213/67) THIS IS AN OEM DEVICE AND THE LOT/SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, A QUERY OF SIMILAR COMPLAINTS FOR THE SERIAL NUMBER AND THE REPORTED FAILURE MODE WAS NOT PERFORMED. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD (B)(6) 2019 THROUGH (B)(6) 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING C-VH-3010, THEY STATED THAT HEMOPRO POWER SOURCE MODEL VH-3010 WITH SERIAL NUMBER (B)(4) THAT THEY WERE INSPECTING SHOWED THAT THE LED LIGHT GOES ON AND OFF DURING USE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255684 T.W. POWER SUPPLY APPARATUS, CAUTERY, RADIOFREQUENCY, BATTERY-POWERED HQQ T.W. POWER SUPPLY 00607567700826

    Patients

    Seq Age Sex Outcome Treatment
    1