BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC STATION

    MDR report key: 7195140 · Received January 16, 2018

    Report

    Report Number
    0001954182-2018-00005
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 11, 2017
    Report Date
    January 16, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPAIRED ON-SITE BY A SERVICE TECHNICIAN. PMA/510(K) NUMBER: K081047; K123188; K133786. THE PREVIOUS REPAIR REPORT FOR ULTRA EVACUATION UNIT WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. THE TECHNICIAN FOUND THAT THE UNIT WAS NOT CONNECTING TO CARTS; WHICH WAS DUE TO THE CONTROL BOARD. HE NOTICED A BURNING SMELL FROM THE POWER SUPPLY. HE REPLACED THE CONTROL BOARD WITH AN EVAC CONTROL BOARD KIT AND THE POWER SUPPLY WITH A POWER SUPPLY KIT. HE THEN VERIFIED THAT THE EVAC WAS FUNCTIONING AS INTENDED AND THEN RETURNED THE EVAC TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO CONTROL BOARD MALFUNCTION. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE CONTROL BOARD WAS REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE EVAC COMM ERRORS OCCURRED DURING CLEANING. DURING INSPECTION BY THE TECHNICIAN, IT WAS NOTICED A BURNING SMELL WAS COMING FROM THE POWER SUPPLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40396 EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1