BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC STATION

    MDR report key: 6843648 · Received September 5, 2017

    Report

    Report Number
    0001954182-2017-00024
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    November 10, 2016
    Report Date
    September 5, 2017
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTS OF BURNING SMELL COMING FROM EVAC. PMA/510(K)#: K081047; K123188; K133786. SINCE THE SERIAL NUMBER WAS UNKNOWN, THE DHR AND REPAIR HISTORY REVIEW CANNOT BE PERFORMED. THE COMPLAINT HISTORY REVIEW WAS NOT REQUIRED SINCE THE REPAIR TECHNICIAN COULD NOT REPRODUCE THE REPORTED EVENT OR FIND ANY OTHER ISSUES WITH THE DEVICE. ON 10 NOVEMBER 2016, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT THE EVAC WAS HAVING BURNING SMELL. PM MEDICAL WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. ON 11 NOVEMBER 2016, THE ACCOUNT¿S TECHNICIAN FOUND NO ISSUE WITH UNIT BUT FOUND THAT THERE WAS STRANGE SMELL FROM THE CART WHICH WAS INVESTIGATE AS PART OF (B)(4). THEN THE TECHNICIAN VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. THE UNIT WAS THEN RETURNED TO SERVICE WITHOUT INCIDENT. PER CRM, REPAIR CHECKLIST WAS NOT REQUIRED FOR THIS SERVICE. THE SERVICE TECHNICIAN WAS UNABLE TO REPRODUCE REPORTED EVENT ON THE EVAC. BASED ON THE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED. 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 THERE WAS A BURNING SMELL COMING FROM THE EVAC DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623543 EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1