BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2000 SYSTEM UNINTERRUPTABLE POWER SUPPLY

    MDR report key: 2698860 · Received January 25, 2012

    Report

    Report Number
    3005248192-2012-00005
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 28, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, THROUGH AN INTERNAL AUDIT INVESTIGATION IT WAS DISCOVERED THAT THE DATE INCLUDED IN THE ORIGINAL MDR REPORT WAS INCORRECT. THE PURPOSE OF THIS MDR FOLLOW-UP REPORT #1 IS TO UPDATE THE ORIGINAL INCORRECT DATE FROM (B)(6) 2011 TO THE CORRECT DATE (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION OPENED FOR THIS EVENT AND IN PROGRESS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ALARM SOUNDED ON THE M2000 SYSTEM UNINTERRUPTABLE POWER SUPPLY (UPS) AND THAT A STRONG ELECTRICAL SMELL FILLED THE LAB. NO VISIBLE SMOKE, FIRE, OR EVIDENCE OF FIRE WAS OBSERVED. THE UPS WAS UNPLUGGED IMMEDIATELY. AN ABBOTT FIELD SERVICE SPECIALIST INSPECTED THE UPS AT THE CUSTOMER SITE AND FOUND IT FUNCTIONAL, BUT NOTED THE ODOR OF BURNT ELECTRONICS. THE M2000ABBOTTRT WAS PLUGGED INTO THE UPS AT THE TIME OF THE INCIDENT; HOWEVER, THERE WAS NO EVIDENCE OF DAMAGE TO THE M2000RT. THE UPS WAS RETURNED TO ABBOTT MOLECULAR. THE VENDOR FOR THE UPS IS (B)(4). THE UPS IS NOT REQUIRED TO PROPERLY OPERATE THE M2000RT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2000 SYSTEM UNINTERRUPTABLE POWER SUPPLY NONE JQW ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1