BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 3886247 · Received April 8, 2014

    Report

    Report Number
    2242352-2014-00423
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. A VISUAL DETERMINED THAT THE POWER SUPPLY CORD WAS NOT RETURNED. A PRE-CAUTERY TEST WAS PERFORMED WITH A REFERENCE EXTENSION CABLE AND HEMOPRO. THE REFERENCE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. WE DID NOT IDENTIFY ANY NON-CONFORMITIES. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE T.W. POWER SUPPLY WAS TESTED AND THE DEVICE DID NOT WORK. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212868 T.W. POWER SUPPLY POWER SUPPLY HQO MAQUET CARDIOVASCULAR, LLC VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI