BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOGICAL INCUBATOR

    MDR report key: 2597370 · Received May 30, 2012

    Report

    Report Number
    MW5025585
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    April 26, 2012
    Report Date
    May 17, 2012
    Manufacturer
    BIOSCIENCE TOOLS
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). WHO YOU ARE: CONSUMER. INCIDENT: I PURCHASED A MODEL, MODEL TC-CW INCUBATOR FROM (B)(6), LOCATED IN (B)(6) DESCRIPTION: THE QUALITY OF THIS PRODUCT IS SO POOR THAT IT PRESENTS A SAFETY HAZARD AFTER ARRIVAL VIA NORMAL SHIPPING. THE CIRCUITY OF THE PRODUCT APPEARS TO BE ATTACHED IMPROPERLY WHICH MEANS THAT THE PRODUCT IS TOO FRAGILE FOR NORMAL CONDITIONS OF USE. THE UNIT I PURCHASED ARRIVED WITH VISIBLY BROKEN WIRES, YET WAS STILL ABLE TO POWER ON AND BE PARTIALLY FUNCTIONAL. AS THESE ELECTRONICS ARE HOUSED IN A METAL ENCLOSURE, THERE IS A HIGH POTENTIAL FOR RECEIVING A SHOCK, THOUGH FORTUNATELY I SUFFERED NO INJURY. INCIDENT DATE: (B)(6) 2012, THIS IS AN ESTIMATE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOGICAL INCUBATOR JTQ BIOSCIENCE TOOLS TC-CW

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR