BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARTEL PRINTER FOR THE I-STAT 1 ANALYZER

    MDR report key: 2192524 · Received June 30, 2011

    Report

    Report Number
    2245578-2011-00104
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MARTEL INSTRUMENTS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 THE BACK OF A MARTEL PRINTER HAD MELTED. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARTEL PRINTER FOR THE I-STAT 1 ANALYZER MARTEL PRINTER JJE MARTEL INSTRUMENTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1