BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 1 ANALYZER

    MDR report key: 2113413 · Received May 25, 2011

    Report

    Report Number
    2245578-2011-00076
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN ANALYZER HAS A BURNT CAPACITOR. BASED ON THE INFORMATION AVAILABLE, THERE WAS NO INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT 1 ANALYZER I-STAT 1 ANALYZER JJE ABBOTT POINT OF CARE INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1