BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDLAB 1245 BLOOD GAS SYSTEM

    MDR report key: 1031276 · Received April 18, 2008

    Report

    Report Number
    1217157-2008-00003
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 15, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS: (ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED): CUSTOMER REPORTED, THE DRS VIEWING THE RESULTS IN PROGRESS DID NOT REALIZE THAT THE NUMBERS IN YELLOW BOXES ARE AN INDICATOR THAT THE SYSTEM IS STILL MEASURING THE BLOOD. THE SYSTEM DID PROVIDE THE CORRECT RESULT, IT WAS CORRECTLY DISPLAYED ON BOTH THE SCREEN AND ON THE ROLL PRINTER. CONCLUSIONS: CUSTOMER FURTHER REPORTS THE SYSTEM DID PROVIDE THE CORRECT RESULT. CUSTOMER STATED THE CORRECT RESULT WAS CORRECTLY DISPLAYED ON BOTH THE SCREEN AND ON THE ROLL PRINTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THEY HAD ONE BLOOD SAMPLE WITH A PH OF 7.00 ON THE INSTRUMENT DISPLAY AND 7.3X ON THE INSTRUMENT PRINT OUT. CUSTOMER REPORTED THAT FOR THIS REASON, A C-SECTION (ABDOMINAL DELIVERY) WAS BEGUN ON THE PT. THE CUSTOMER FURTHER REPORTED THAT WHEN THE C-SECTION WAS COMPLETED AND WHEN THEY CAME BACK TO THE INSTRUMENT, THE PRINTOUT WAS 7.3 AND IT WAS DETERMINED THAT THE C-SECTION WAS NOT NECESSARY. RESULTS OBTAINED BY PHYSICIAN WERE READ FROM INSTRUMENT DISPLAY BEFORE THE TEST WAS COMPLETED. THE CORRECT FINAL READING FOR PH WOULD HAVE BEEN DISPLAYED WITHIN 30 SECS. THE CORRECT RESULT WAS DISPLAYED IN BLACK NUMBERS ON A BLUE BACKGROUND. THE PHYSICIAN PREMATURELY ACTED ON A RESULT POSTED IN A YELLOW BOX ON DISPLAY INDICATING RESULTS UPDATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1245 BLOOD GAS SYSTEM RAPIDLAB 1245 CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD RL1245 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK