BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3118600 · Received May 17, 2013

    Report

    Report Number
    1319681-2013-00106
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT THE CUSTOMER HAD AN ACUTE REACTION WITH SHORTNESS OF BREATH AFTER INHALING SMOKE THAT WAS COMING FROM THE VITROS 5600 INTEGRATED. THE CUSTOMER, WHO HAD A PRE-EXISTING CONDITION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), RECEIVED MEDICAL TREATMENT (OXYGEN AND ALBUTEROL) IN THE EMERGENCY ROOM AND WAS ABLE TO RETURN TO WORK SHORTLY THEREAFTER. THE OCD FE DETERMINED THAT ELECTRICAL CONNECTORS/CABLES AT THE MASTER COMPUTER HAD MELTED GENERATING THE SMOKE. THE FE SERVICED THE VITROS 5600 INTEGRATED SYSTEM TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT WAS INSTRUMENT RELATED. THE ISSUE HAS BEEN COMMUNICATED TO CUSTOMERS THROUGH CUSTOMER LETTER (B)(4). THE FDA'S (B)(6) DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(4) 2013 PER RECALL NUMBER 1319681-05/14/2013-001-C.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT IN WHICH BLACK SMOKE WAS EMITTING FROM THE VITROS 5600 INTEGRATED SYSTEM CAUSING A CUSTOMER TO BE OVERCOME BY SMOKE INHALATION REQUIRING MEDICAL INTERVENTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219648 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1