BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 8084664 · Received November 19, 2018

    Report

    Report Number
    9610816-2018-00318
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 12, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A HUGO TECHNOLOGIES ENGINEER (HTE) WENT ONSITE AND COLLECTED THE ALARM REVIEW LOG FROM THE BEDSIDE MONITOR. DURING BOOT-UP, SEVERAL INOPS WERE DISPLAYED ON THE X2, SUCH AS "CHECK MONITOR FUNCTION," "SPO2 EQUIPMENT MALFUNCTION," "ECG EQUIPMENT MALFUNCTION," AND "NON-INVASIVE BLOOD PRESSURE (NBP) EQUIPMENT MALFUNCTION." THE X2 WAS SENT TO THE PHILIPS BENCH FOR EVALUATION AND REPAIR, SPECIFICALLY FOR AN INSPECTION OF POTENTIALLY DAMAGED PINS ON THE DEVICE. WHEN THE HTE PERFORMED A POWER-ON TEST, A LEADS TEST AND A PERFORMANCE ASSURANCE TEST PRIOR TO THE REPAIR OF THE DEVICE IN THE BENCH USING THE ECG LEADS AND SPO2 SENSOR SENT IN BY THE HOSPITAL, THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE DEVICE WORKED AS INTENDED AND PASSED A FULL ELECTRICAL TEST. THE EXACT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. THE HTE REPLACED THE PARAMETER BOARD TO RESOLVE THE REPORTED ISSUE. ALL FUNCTIONAL AND SAFETY TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER OPERATING AS INTENDED. NO FURTHER CALLS FROM THE CUSTOMER WERE LOGGED REGARDING THE REPORTED DEVICE AND ISSUE. THE PROBLEM WAS SOLVED BY REPLACEMENT OF THE MS_X2 PCA ECG-5LD/FAST SPO2/P&T VER2 (453564563281). AS A PRECAUTION TO PREVENT A RECURRENCE OF THIS INTERMITTENT ISSUE, THE HTE ALSO REPLACED THE MS_X2 X2/MP2 MAINBOARD VER2 (453564387761) AND THE MS_X2 X2/MP2 MSL POWERBOARD VER2 (453564392641) WHICH IS CONSIDERED AS ALL THAT IS WARRANTED FOR THIS MALFUNCTION. THE REPAIRED PRODUCT REMAINS AT THE CUSTOMER SITE. THE DEVICE FAILED TO WORK AS INTENDED. THIS ISSUE WAS CAUSED BY A MALFUNCTION OF THE DEVICE AND WAS RESOLVED BY THE REPLACEMENT OF THE PARAMETER BOARD. AS A PRECAUTION TO PREVENT A RECURRENCE OF THIS INTERMITTENT PROBLEM, THE HUGO TECHNOLOGIES ENGINEER ALSO REPLACED THE MAIN BOARD AND THE POWER BOARD. NO FURTHER CALLS FROM THE CUSTOMER WERE LOGGED REGARDING THE REPORTED DEVICE AND ISSUE. THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THIS FAILURE REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "THE SURGEON PASSED A CYSTOSCOPE INTO THE PATIENTS BLADDER WITHOUT EVENT, BUT ON PASSING A GUIDE WIRE INTO THE URETHRA THE MONITOR REGISTERED HYPOTENSION OF 72 OVER 4?, THIS WAS APPROPRIATELY TREATED BY THE ANAESTHETIST AND A CHECK OF BLOOD PRESSURE SHOWED A FURTHER DROP TO 48 SYSTOLIC , DIASTOLIC HAS NOT BEEN RECORDED. THE ANAESTHETIST COULD NOT FEEL A CAROTID PULSE AND HELP WAS SUMMONED IMMEDIATELY, AT THIS TIME THE MONITOR DID NOT DISPLAY ANY HEART RATE, PULSE, SPO2 OR CAPNOGRAPHY. PATIENT RESUSCITATION BEGAN USING THE MONITOR ON THE DEFIBRILLATOR, CARDIAC MASSAGE AND ADRENALINE WERE ADMINISTERED IN LINE WITH THE FINDINGS, FOLLOWING THIS THE ANAESTHETIC MACHINE MONITOR BEGAN TO DISPLAY PATIENT VITAL STATISTICS THOUGH SOMEWHAT INTERMITTENT INITIALLY.´"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924174 INTELLIVUE MULTI MEASUREMENT SERVER X2 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention