BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE KIT

    MDR report key: 6731067 · Received July 21, 2017

    Report

    Report Number
    2031172-2017-00731
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 27, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    GWQ
    PMA / PMN Number
    K151644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED MODULE WAS EVALUATED. EXTERNAL VISUAL INSPECTION SHOWED A BROKEN OFF AND MISSING PIN 1 ON PATIENT CABLE. WHEN CONNECTED TO A MONITOR THE MONITOR DISPLAYED "HIGH IMPEDANCE DETECTED" AND NO WAVEFORM WAS DISPLAYED WITH TEST PLUG. THE MODULE WAS CONNECTED TO A MONITOR WITH A KNOWN GOOD PATIENT CABLE AND PASSED ALL FUNCTIONAL TESTS. THE CUSTOMER COMPLAINT WAS DUPLICATED FOR HIGH IMPEDANCE DUE TO THE BROKEN PIN ON THE PATIENT CABLE, THE MODULE PASSED ALL FUNCTIONAL TESTS AND THE CUSTOMER COMPLAINT REGARDING PSI VALUES WAS NOT DUPLICATED. INITIAL REPORTER ZIP CODE EXCEEDED MAXIMUM ALLOWABLE DIGITS, ZIP CODE IS AS FOLLOWS: (B)(6), CORRECTED DATA: CORRECTED FROM (B)(6). 510K# CORRECTED FROM K140188 TO K151644.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "THERE HAPPENED THE ISSUE THAT CT IMPEDANCE INDICATOR BECAME BLUE. HOWEVER THE REPLACEMENT MODULE RESOLVED THE ISSUE. THERE WAS NO PROBLEM WITH THE SENSOR. THE IMPEDANCE READING WAS 10 TIMES COMPARED TO THE TYPICAL. ALSO, THERE WAS ANOTHER ISSUE. ALTHOUGH A PATIENT WAS UNDER SEDATION, THE ISSUE THAT PSI VALUE WAS VERY HIGH OCCURRED SEVERAL TIMES." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512907 SEDLINE KIT ELECTROENCEPHALOGRAPH GWQ MASIMO - 40 PARKER 25761

    Patients

    Seq Age Sex Outcome Treatment
    1