BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE-E-VAC 3

    MDR report key: 3694806 · Received December 13, 2013

    Report

    Report Number
    1419185-2013-00004
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    BTA
    PMA / PMN Number
    K062610
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER PAT GALLAGHER BIOMED, THE UNIT INVOLVED WAS ON A CRASH CART AND WAS RARELY USED. HE WAS NOTIFIED THAT THE UNIT WAS NOT WORKING, RETRIEVED THE UNIT AND POWERED IT ON BUT IT DID NOT WORK. HE OPENED THE UNIT AND NOTICED THE BURNT SMELL AND THE BOARD DAMAGE. HE ALSO NOTICED A LOOSE PART INSIDE OF UNIT. UNIT WAS RETURNED AND DAMAGE WAS CONFIRMED TO BE A BURNT BOARD. THIS UNIT AND BOARD ARE CURRENTLY UNDER FURTHER INVESTIGATION BY OHIO MEDICAL CORPORATION. UPDATES WILL BE PROVIDED AS THEY OCCUR.

    Description of Event or Problem · 1

    UNIT WAS FOUND BY BIOMED WITH A DAMAGED/BURNT PCB CONTROL BOARD. EVENTS LEADING TO DAMAGE ARE UNKNOWN AS UNIT WAS RARELY USED (PER BIOMED). COMPLAINT "DAMAGED BOARD" WAS FORWARDED TO OHIO MEDICAL ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654254 CARE-E-VAC 3 CEV 3 PORTABLE VACUUM PUMP BTA OHIO MEDICAL CORPORATION 758000 CEB111001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA