BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION

    MDR report key: 7592375 · Received June 12, 2018

    Report

    Report Number
    1051786-2018-00011
    Event Type
    Death
    Date Received
    June 12, 2018
    Date of Event
    May 22, 2018
    Report Date
    May 23, 2018
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER ( FSE) WAS DISPATCHED TO THE HOSPITAL TO EVALUATE THE REPORTED ISSUES WITH THE DEVICE'S TIME AND TREND DATA. ACCORDING TO THE FSE¿S NOTES IN THE CASE, THE CUSTOMER WANTED VITAL SIGNS DATA PRINTED AND SAVED AND WANTED THE FSE ONSITE TO DO IT. THE FSE FOUND THAT THE BATTERY ON THE DEVICE¿S MOTHERBOARD WOULD NOT KEEP TIME AND THAT THE TIME ON THE REMOTE MONITOR IN THE CONTROL ROOM WAS SLOW BY 1 HOUR 15 MINUTES. THE FSE OFFERED TO ORDER A NEW MOTHERBOARD AND PROVIDED THE CUSTOMER WITH THE PART NUMBER AND PRICE, BUT THE CUSTOMER INDICATED THAT THEY WANTED TO WAIT. WHILE DOING A PREVENTATIVE MAINTENANCE (PM) ON THE DEVICE, THE FSE NOTED THAT THE CUSTOMER SEQUESTERED THE DEVICE AND DID NOT WANT THE FSE TO FINISH THE PM. THE CUSTOMER ASKED THE FSE TO FINISH THE PM AFTER THE REPAIR OF THE TIME AND TREND DATA ISSUE AND THE FSE ADVISED THE CUSTOMER THAT HE NEEDED TO FINISH TESTING. THE FSE CONFIRMED THAT THE DEVICE FAILED THE DATE AND TIME PA CHECK ON THE CART, BUT DID NOT FINISH THE NIBP OR AGENT TESTS. THE FSE ADVISED THE CUSTOMER THAT THE DEVICE SHOULD BE REMOVED FROM SERVICE UNTIL IT WAS FULLY TESTED. THE CUSTOMER REQUESTED A LOANER DEVICE TO USE UNTIL THE ISSUES WITH THEIR DEVICE WERE RESOLVED. THE FSE FURTHER DOCUMENTED THAT A LOANER WAS GIVEN TO THE CUSTOMER AS REQUESTED AND THAT THE CUSTOMER WILL NOT LET ANYONE TOUCH THEIR DEVICE. THE FSE REPORTED THAT THE CUSTOMER'S DEVICE WAS REMOVED FROM SERVICE AND WAS ADVISED THAT THE HOSPITAL¿S LEGAL DEPARTMENT WAS NOT ALLOWING THEM TO SHARE ANY OF THE INFORMATION THAT PHILIPS HAD REQUESTED. THE HOSPITAL¿S RISK MANAGER ADVISED THAT SHE WOULD PROVIDE THE INVESTIGATOR WITH AN ANSWER TO THE NON PATIENT SPECIFIC QUESTIONS AS SOON AS SHE WAS APPROVED TO DO SO. THE INVESTIGATOR FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER ADVISED THAT THEY HAD THE INFORMATION THAT PHILIPS WAS REQUESTING, BUT THAT THEY WERE ALSO LOOKING FOR INFORMATION FROM PHILPS AND THE INVESTIGATOR PROVIDED THE INFORMATION REQUESTED. THE INVESTIGATOR FOLLOWED UP WITH THE RISK MANAGER AGAIN BUT THE RISK MANAGER ADVISED THE INVESTIGATOR THAT SHE HAD THOUGHT SOMEONE ELSE AT THEIR FACILITY PROVIDED PHILIPS WITH THE REQUESTED INFORMATION, WHICH THEY HAD NOT, AND THAT SHE WAS GOING TO FORWARD THE INVESTIGATOR¿S REQUEST TO ANOTHER INDIVIDUAL. AS OF LAST COMMUNICATION WITH THE CUSTOMER, THE CUSTOMER'S DEVICE REMAINS OUT OF SERVICE AT THE CUSTOMER SITE AND THE LOANER DEVICE THAT WAS PROVIDED TO THE CUSTOMER WAS IN USE. THE INVESTIGATOR REVIEWED ONEEMS FOR ADDITIONAL CALLS FOR THIS DEVICE AND REPORTED ISSUE AND FOUND NO FURTHER RELATED CALLS. THE FSE CLOSED OUT THE CALL DUE TO LACK OF DIRECTION FROM THE CUSTOMER. THE CUSTOMER INDICATED THAT THEY WERE NOT SURE WHAT THEY WANT DONE. THE INVESTIGATOR IS CLOSING THIS COMPLAINT UNDER GOOD FAITH EFFORT MADE, BUT THE COMPLAINT CAN BE REOPENED UPON RECEIPT OF ADDITIONAL INFORMATION. THE CUSTOMER REFUSED TO PROVIDE ACCESS TO THE DEVICE FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ADDITIONAL INFORMATION REGARDING THE INCIDENT WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE FIELD SERVICE ENGINEER THAT HE NEEDED ASSISTANCE WITH PULLING PATIENT INFO FROM THE PRECESS BLUE RELATING TO A PATIENT INCIDENT. THE FSE REPORTED THAT THE PATIENT INCIDENT OCCURRED (B)(6) BETWEEN 10:00 AM - 10:30 AM. THE FSE REPORTED THAT THE TIME APPEARS INCORRECT ON THE CRD AND THAT THE TREND DATA ON THE CRD APPEARS TO BE DIFFERENT FROM THE TREND DATA ON THE CART. IT WAS ALSO REPORTED THAT SOME OF THE TREND DATA WAS MISSING. IT WAS REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433777 INVIVO CORPORATION PATIENT MONITOR MWI INVIVO CORPORATION 865323

    Patients

    Seq Age Sex Outcome Treatment
    1 Death