BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1456096 · Received August 28, 2009

    Report

    Report Number
    2919069-2009-00305
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    August 6, 2009
    Report Date
    August 6, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) A FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE CELL-DYN 1800 INSTRUMENT AND NOTED THAT THE INSTRUMENT WAS PLUGGED INTO A DEFECTIVE POWER STRIP/SURGE PROTECTOR (SURGE LIGHT WAS ON WITH NO LOAD APPLIED). THE SURGE PROTECTOR WAS PLUGGED INTO A GFI RECEPTACLE. THE GFI RECEPTACLE COULD NOT HANDLE THE NORMAL OPERATING LOAD OF THE CELL-DYN 1800 INSTRUMENT WITHOUT TRIPPING. THE FSR ALSO NOTED SEVERAL OTHER DEVICES MAY HAVE CONTRIBUTED TO THIS, INCLUDING A LASER PRINTER, AND MULTIPLE OTHER DEVICES ON THE GFI CIRCUIT. THE FSR REPLACED THE POWER SUPPLY ON THE CELL-DYN 1800 INSTRUMENT. THE FSR PLUGGED THE CELL-DYN 1800 INSTRUMENT INTO A REGULAR NON-GFI RECEPTACLE AND VERIFIED ALL VOLTAGES WERE WITHIN RANGE. THE FSR BELIEVED THAT THE CORE ISSUE WAS DUE TO A DEFECTIVE DIODE BASED POWER STRIP ON AN OVERLOADED GFI CIRCUIT. THE FSR ADVISED THE CUSTOMER REGARDING THE ISSUE. THE INSTRUMENT WAS OPERATING PER SPECIFICATIONS. THE POWER SUPPLY, LIST NUMBER 8921029202 AND (B) (4), WAS RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION, WHEN THE POWER SUPPLY WAS POWERED ON, THE SWITCHING POWER SUPPLY (PART NUMBER 4056276) GENERATED A "MACHINE GUN SHOT" SOUND AND SMOKE. THE INVESTIGATOR TURNED OFF THE POWER IMMEDIATELY. THE INVESTIGATOR NOTED THAT THE CABLE CONNECTOR OF THE SWITCHING POWER SUPPLY HAD DUST AROUND IT. THE CAUSE OF THE POWER SUPPLY FAILURE IS INCONCLUSIVE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE ISSUE UNDER INVESTIGATION. A NON-STATISTICAL TREND (NST) COMPLAINT REVIEW WAS PERFORMED FOR THE REPORTED ISSUE AND NO NST WAS IDENTIFIED. BASED ON THE INVESTIGATION OF THIS COMPLAINT, NO PRODUCT DEFICIENCY WAS IDENTIFIED ON THE CELL-DYN 1800 INSTRUMENT FOR THE REPORTED ISSUE. THE ISSUE WAS DUE TO A DEFECTIVE DIODE BASED POWER STRIP ON AN OVERLOADED GFI CIRCUIT. THERE WAS NO SYSTEMIC ISSUE FOR THE CELL-DYN 1800 PRODUCT LINE.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AFTER RUNNING A COMPLETE BLOOD COUNT ON THE CELL-DYN 1800 ANALYZER, THE SCREEN WAS BLANK AND A BURNING SMELL WAS NOTED AND SMOKE OBSERVED. THE INSTRUMENT BLEW A SWITCH, AND WHILE UNPLUGGING THE INSTRUMENT FROM THE WALL OUTLET, A PHYSICIAN RECEIVED A SHOCK. NO MEDICAL TREATMENT WAS REQUIRED. FIELD SERVICE WAS DISPATCHED TO INSPECT THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE USE OF THIS DRILL IN ORAL SURGERY, IT GOT NOISY, HOT AND CONSOLE IN USE GENERATED A MAGNETIC FIELD ERROR MESSAGE. THE USER FELT THE DEVICE GET HOT, DISCONTINUED USE AND OBTAINED ANOTHER HANDPIECE TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability