BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDLINE PATIENT CABLE

    MDR report key: 6503700 · Received April 19, 2017

    Report

    Report Number
    2031172-2017-00476
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    March 27, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    GWQ
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED CABLE WAS EVALUATED. EXTERNAL VISUAL INSPECTION SHOWED NO PHYSICAL DAMAGE. THE CABLE FAILED CONTINUITY TESTING DUE TO A BROKEN WIRE AT THE SOLDER JOINT ASSEMBLY. WHEN CONNECTED TO A MONITOR WITH A TEST SENSOR, A "NO SENSOR CONNECTED" ERROR WAS DISPLAYED ON THE MONITOR., CORRECTED DATA: COMMON DEVICE NAME WAS CORRECTED FROM OXIMETER TO ELECTROENCEPHALOGRAPH. WAS CORRECTED FROM DQA TO GWQ. MODEL # CORRECTED FROM 3637 TO 23858. LOT # CORRECTED FROM A14E0732 TO A14E072.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOT OF INTERFERENCE ON THE EEG SIGNAL, A DISTURBED PSI, AND SOME TIMES LATER NO VALUE. CUSTOMER HAS A LOT OF MEASUREMENT PROBLEMS. THERE ARE POSSIBLE MULTIPLE INTERFERENCE IN THE ROOMS. THE CABLES WERE POSSIBLY CLEANED WITH A DAMP SHEET. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AT THE BEGINNING, THE PSI VALUE WAS DIFFICULT TO OBTAIN ON THE SCREEN. SOMETIMES THE PSI APPEARED AND SEEM TO BE ACCURATE AND SOMETIMES THE VALUE WAS INACCURATE. THE EEG LINE WAS ONLY A RIGHT LINE AND NO PSI VALUE. THERE WERE NO ERROR MESSAGES FOR THE ELECTRODE STATUS AND NO AUDIBLE ALARM. WHEN THE PSI WAS "----", THE EEG HAD A RIGHT LINE, THERE WAS AN ERROR MESSAGE "NO CABLE PATIENT CONNECTED". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286255 SEDLINE PATIENT CABLE ELECTROENCEPHALOGRAPH GWQ MASIMO - 40 PARKER 23858 A14E072

    Patients

    Seq Age Sex Outcome Treatment
    1