BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 7577818 · Received June 7, 2018

    Report

    Report Number
    1051786-2018-00010
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Report Date
    May 28, 2018
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY THE DISTRIBUTOR, ADEMIA. REFER TO THE ATTACHED SERVICE REPORT. THE REPORT INDICATES THAT THE DEVICE WAS TESTED MANY TIMES AND THE PROBLEM COULD NOT BE DUPLICATED. THE REPORT ALSO INDICATES THAT THE DEVICE MEASURED PERFECTLY EACH TIME. THE REPORT FURTHER STATES THAT CONSUMABLES (CUFF/HOSE) WERE PUT IN THE TRASH BY THE CUSTOMER. THEREFORE, THEY WERE NOT AVAILABLE FOR EVALUATION WITH THE DEVICE. IT WAS STATED THAT, PRIOR TO THE REPORTED QUESTIONABLE NIBP READING, THE DEVICE DISPLAYED A CUFF LEAK INOP. ACCORDING TO THE DEVICE¿S INSTRUCTIONS FOR USE [IFU] (PN: 989803172891; REVISION F, PAGE 11-11), THIS INOP CAN BE CAUSED BY A LEAK IN THE CUFF OR HOSE. THE IFU STATES THAT THE CUFF AND HOSE SHOULD BE CHECKED FOR LEAKS AND THAT IT SHOULD BE MADE SURE THAT THE HOSE FITTINGS ARE TIGHT. THE CUSTOMER INDICATED THAT THEY TIGHTENED THE CUFF CONNECTION, BUT DID NOT INDICATE THAT THEY CHECKED THE HOSE AND CUFF FOR LEAKS. ADDITIONALLY, THE IFU STATES THAT THIS INOP CAN BE CAUSED BY TOO MUCH PATIENT MOVEMENT CAUSING EXCESSIVE PRESSURE CHANGES TO THE CUFF DURING MEASUREMENT. THE IFU ALSO STATES THAT THE USER SHOULD TRY TO MINIMIZE PATIENT MOVEMENT. IT IS NOT KNOWN IF PATIENT MOVEMENT WAS A POSSIBLE FACTOR IN THIS INCIDENT. THE INCIDENT REPORT OBTAINED BY PHILIPS INDICATES THAT THE PATIENT¿S "TASYST" READING OF 200 WAS OBTAINED BY THE TRANSPORT MONITOR FOLLOWING THE MRI EXAMINATION. IT IS NOT KNOWN IF THIS MEASUREMENT WAS TAKEN IN THIS MANNER BECAUSE THE DEVICE WAS NOT FUNCTIONAL (POSSIBLY STILL PRODUCING THE CUFF LEAK INOP) OR IF THE CUSTOMER CHOSE TO OBTAIN THE READING USING ANOTHER METHOD. IT WAS REPORTED BY THE DISTRIBUTOR THAT, AS A PRECAUTION, THE DEVICE¿S NIBP PART ASSEMBLY (PN: 453564088651; ASSY, NIBP PNEUMATICS, WPU) WAS CHANGED. THE CUSTOMER ALSO REPORTED REPLACING THE BLOOD PRESSURE CUFF AND HOSE. ACCORDING TO THE DISTRIBUTOR, THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. THE CUSTOMER CLAIMED THAT A PATIENT WAS TREATED BASED ON A BLOOD PRESSURE READING GIVEN BY THE DEVICE. EVALUATION OF THE DEVICE BY THE DISTRIBUTOR DID NOT DUPLICATE THE REPORTED ISSUE. THERE IS EVIDENCE THAT THE BLOOD PRESSURE CUFF AND/OR HOSE IN USE HAD A LEAK, AS INDICATED BY THE FACT THAT THE DEVICE PRODUCED A CUFF LEAK INOP PRIOR TO THE REPORTED FAULTY READING. THEREFORE, THEY WERE NOT AVAILABLE FOR FURTHER EVALUATION AND CONFIRMATION THAT ONE OR BOTH OF THESE ITEMS CONTRIBUTED TO THE REPORTED ISSUE. THE INVESTIGATION SHOWED THAT THE DEVICE PERFORMED AS INTENDED BY PROVIDING PROPER INDICATION OF A CUFF LEAK INOP CONDITION. AS A RESULT OF THE INOP PROVIDED BY THE DEVICE AND PER THE DEVICE¿S LABELING, THE CLINICIAN SHOULD HAVE CHECKED THE PATIENT¿S VITAL SIGNS BY ALTERNATE MEANS BEFORE ADMINISTERING ANY MEDICATION. 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. CAN NOT CONFIRM SERIAL NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PATIENT INCIDENT INVOLVING A BLOOD PRESSURE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423157 INVIVO CORPORATION PATIENT MONITOR MWI INVIVO CORPORATION 865323

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other