BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MWI

    MDR report key: 8290034 · Received January 30, 2019

    Report

    Report Number
    1051786-2019-00005
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 22, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838039131
    PMA / PMN Number
    K152330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL ADVISED PHILIPS TECHNICAL SUPPORT THAT THEY HAD PLANNED TO EVALUATE THE DEVICE THEMSELVES. PHILIPS REQUESTED THE OUTCOME OF THIS EVALUATION FROM THE HOSPITAL, BUT THIS HAS NOT BEEN PROVIDED. THE HOSPITAL THEN REQUESTED THAT PHILIPS EVALUATE THE DEVICE. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE HOSPITAL SITE. THE FSE CONTACTED THE HOSPITAL IN ORDER TO SCHEDULE THE VISIT TO THE HOSPITAL. THE HOSPITAL ADVISED THE FSE AT THAT TIME THAT THE DEVICE HAD BEEN PUT BACK INTO SERVICE FOLLOWING THE INCIDENT. WHEN THE FSE ARRIVED AT THE HOSPITAL, HE INSPECTED THE WIRELESS SPO2 MODULE, CABLE AND FINGER PROBE AND FOUND NO DAMAGE TO THESE ITEMS. THE FSE INSERTED A BATTERY INTO THE SPO2 MODULE AND IT POWERED ON AND OPERATED AS EXPECTED. THE FSE ALSO INSPECTED THE WIRELESS ECG MODULE AND CABLE AND FOUND NO DAMAGE TO THESE ITEMS. THE FSE INSERTED BATTERIES INTO THE ECG MODULE AND IT POWERED ON AND OPERATED AS EXPECTED. THE FSE ALSO TESTED THE PATIENT MONITOR AND FOUND IT TO BE OPERATING AS EXPECTED. THE FSE THEN PERFORMED SPO2 AND ECG VERIFICATION TESTING PER THE DEVICE¿S SERVICE MANUAL INSTRUCTIONS AND THE DEVICE PASSED ALL TESTING. NO SIGNAL LOSS WAS EXPERIENCED DURING ALL TESTING PERFORMED. THE FSE ALSO TESTED THE DEVICE¿S ALARMS AND FOUND THAT THE DEVICE ALARMED AS EXPECTED. ADDITIONALLY, THE FSE INSPECTED THE REMOTE MONITOR IN THE CONTROL ROOM (IP5) AND FOUND THE FLEXIBLE ANTENNA (PN: 989803176511) TO BE LOCATED ON THE WINDOW LEDGE IN A HORIZONTAL POSITION. THE FLEXIBLE ANTENNA AIDS IN COMMUNICATION BETWEEN THE PATIENT MONITOR IN THE MAGNET ROOM AND THE REMOTE MONITOR IN THE CONTROL ROOM AND IS INTENDED TO BE MOUNTED ON THE CONTROL ROOM WINDOW. THE FSE POWERED ON THE IP5 MONITOR AND FOUND IT OPERATING AS EXPECTED. IN CONCLUSION, THE HOSPITAL REPORTED PROBLEM OF INTERMITTENT SIGNAL LOSS FOR SPO2 WAS NOT DUPLICATED OR CONFIRMED DURING PHILIPS EVALUATION OF THE DEVICE. HOWEVER, THE POSITION IN WHICH THE FSE FOUND THE FLEXIBLE ANTENNA LIKELY CONTRIBUTED TO ANY COMMUNICATION/SIGNAL DROP OUT EXPERIENCED AT THE REMOTE MONITOR IN THE CONTROL ROOM. THE FSE ADVISED THE HOSPITAL¿S BIOMED OF HIS FINDINGS RELATED TO THE POSITION OF THE FLEX ANTENNA. TO CORRECT THIS, THE BIOMED REPOSITIONED THE FLEX ANTENNA. THE DEVICE REMAINS AT THE HOSPITAL SITE. 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 UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE HOSPITAL'S BIOMED REPORTED THAT A PATIENT CODED WHILE ON THE MONITOR AND, DURING THE CODE, THE DEVICE WAS DISPLAYING INTERMITTENT SIGNAL LOSS FOR SPO2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83476 MWI PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 866185 00884838039131

    Patients

    Seq Age Sex Outcome Treatment
    1