BEUDAMED
    FDA Adverse Event Death Summary report: N

    3160 MRI PATIENT MONITOR

    MDR report key: 6356311 · Received February 24, 2017

    Report

    Report Number
    1051786-2017-00004
    Event Type
    Death
    Date Received
    February 24, 2017
    Date of Event
    January 16, 2017
    Report Date
    February 15, 2017
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT A CRITICAL PATIENT DIED WHILE THE DEVICE WAS IN USE FOR PATIENT MONITORING. IT WAS LATER CLARIFIED THAT THE PATIENT WAS IN THE MRI, BUT THE HOSPITAL WAS NOT USING THE INVIVO DEVICE WHEN THE INCIDENT OCCURRED. THE PATIENT REPORTEDLY DID NOT EXPIRE IN THE MRI, BUT IT WAS REPORTED THAT THE PATIENT CODED IN THE MRI AND THE PATIENT WAS RESUSCITATED. THE PATIENT EXPIRED 2 DAYS LATER. THE HOSPITAL WAS NOT USING THE INVIVO DEVICE WHEN THE CODE IN THE MRI OCCURRED AND THE PATIENT WAS NOT CONNECTED TO THE INVIVO DEVICE WHEN SHE EXPIRED. IT WAS REPORTED THAT THE INVIVO DEVICE WAS NOT IN USE IN THE MRI BECAUSE HOSPITAL CARE PROVIDERS ORDERING MRI EXAMINATIONS FOR CRITICAL PATIENTS DID NOT KNOW THE DEVICE OR MONITORING WAS AVAILABLE. THE HOSPITAL STANDARD WAS TO REMOVE ANY MONITORING BEFORE THE PATIENT ENTERED THE MRI AND THEN PATIENT MONITORING WAS REESTABLISHED WHEN THE MRI WAS FINISHED. THIS WOULD INDICATE THAT PATIENTS WERE NOT MONITORED WHILE THE MRI EXAMINATIONS TOOK PLACE. THE CUSTOMER DID NOT REPORT THAT THE INVIVO DEVICE WAS MALFUNCTIONING OR HAD MALFUNCTIONED. AS A RESULT, WE ARE NOT CONSIDERING THAT THE INVIVO DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT SINCE IT WAS AVAILABLE AND FUNCTIONING, BUT IT WAS NOT PUT INTO USE BY THE HOSPITAL. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DIED WHILE USING THE DEVICE AND THEY WANTED THE DEVICE EVALUATED. IT WAS REPORTED THAT ONLY SPO2 WAS BEING MONITORED. IT WAS ALSO REPORTED THAT THE HOSPITAL STAFF BELIEVES ONLY THE DISPLAY POWER BUTTON WAS TURNED ON AND NOT THE WPU/CART. IF THIS WERE THE CASE, THE DEVICE'S DISPLAY WOULD BE BLANK AND THE PATIENT VITAL SIGNS WOULD NOT BEEN SEEN BY THE CLINICIAN. ADDITIONAL INFORMATION IS PENDING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138779 3160 MRI PATIENT MONITOR PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death