BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP5

    MDR report key: 6339912 · Received February 17, 2017

    Report

    Report Number
    9610816-2017-00055
    Event Type
    Death
    Date Received
    February 17, 2017
    Report Date
    January 18, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT TO UPDATE THE PRO CODE FROM MHK TO BZQ PER FDA REQUEST. THE INVESTIGATION IS ONGOING AND A FOLLOW-UP WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE CUSTOMER REPORTED THAT THE INTELLIVUE MP5 PATIENT MONITOR DID NOT SUCCESSFULLY TAKE A NON-INVASIVE BLOOD PRESSURE (NBP) MEASUREMENT DURING THE EFFORT TO RESCUE A PATIENT. THE FSE TESTED THE INTELLIVUE MP5 PATIENT MONITOR AND FOUND THE DEVICE TO BE WORKING AS SPECIFIED AND EXPECTED DURING THE ONSITE INVESTIGATION. IT HAS BEEN ESTABLISHED THAT THERE WAS NO TROUBLE FOUND. DESPITE SEVERAL ATTEMPTS TO OBTAIN DETAILS WHETHER A TECHNICAL ALARM (INOP) WAS DISPLAYED ON THE DEVICE DURING THE INCIDENT, THIS INFORMATION WAS NOT PROVIDED. THE FSE ALSO STATED THAT IT WAS DETERMINED THAT THE NBP CUFF USED WITH THE PATIENT MONITOR WAS LEAKING AND MOST LIKELY THE ROOT CAUSE FOR THE REPORTED FAILURE TO MEASURE THE NBP. THE NBP CUFF FAILURE WAS INVESTIGATED IN A SEPARATE COMPLAINT. AS THE PHILIPS FIELD SERVICE ENGINEER FOUND THE MONITOR TO BE OPERATING CORRECTLY, THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE INFORMATION PROVIDED BY THE FSE DOES NOT SUPPORT THAT THERE WAS A MALFUNCTION OF THE MONITOR, HOWEVER, A MALFUNCTION CANNOT BE RULED OUT. THE HOSPITAL'S CLINICAL STAFF DID NOT ALLEGE THE PATIENT DEATH TO BE A DIRECT RESULT OF A MALFUNCTION OF THE MONITOR. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. THE PRODUCT REMAINS AT THE CUSTOMER SITE. THE INCIDENT TOOK PLACE IN (B)(6) 2017. NO ADDITIONAL INFORMATION REGARDING THE EXACT LOCATION, TIME, AND DATE OF THE INCIDENT WAS PROVIDED BY THE HOSPITAL. PATIENT INFORMATION WAS REQUESTED AND NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "THE INTELLIVUE MP5 IS A SAFETY HAZARD". THE DEVICE WAS USED FOR MONITORING AT THE TIME OF THE ALLEGED MALFUNCTION. THE DEATH OF A PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121045 MP5 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death