BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MWI

    MDR report key: 6405984 · Received March 15, 2017

    Report

    Report Number
    1051786-2017-00005
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 15, 2017
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K152330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT REPORTED THAT SHE HAD BRUISES ON HER STERNUM AREA, AROUND WHERE THE QUADTRODE ELECTRODE WAS PLACED, AFTER SHE WAS SENT HOME FROM THE HOSPITAL. THE PATIENT CLAIMED THAT SOME OF THE BRUISING LOOKED AS IF IT WERE A THUMBPRINT. ACCORDING TO THE CUSTOMER FEEDBACK, NO PRODUCT WAS AVAILABLE FOR EVALUATION. THE CUSTOMER CONFIRMED THAT THE ACCESSORIES THAT HAD BEEN IN USE WERE DISCARDED. THE INVESTIGATOR CONSULTED WITH PHILIPS RESEARCH AND DEVELOPMENT AND ENGINEERING ABOUT THE REPORTED PATIENT RESPONSE. BOTH AGREED THAT THE REPORTED SYMPTOM COULD NOT BE RELATED TO THE QUADTRODE. THEY STATED THAT, IF THE PATIENT HAS A HISTORY OF BRUISING EASILY, THE SYMPTOM COULD HAVE BEEN CAUSED BY THE CLINICIAN WHO ATTACHED THE QUADTRODE TO THE PATIENT, THEN ATTACHED THE LEAD WIRES BY PRESSING THEM FIRMLY ON TO THE ELECTRODES. THE HOSPITAL REPRESENTATIVE REPORTED THAT THE HOSPITAL¿S PHYSICIAN ALSO POSED THIS TO THE PATIENT AS A LIKELY REASON FOR THE REPORTED BRUISING. THE HOSPITAL WAS ASKED IF THE PATIENT HAD A HISTORY OF EASY BRUISING, BUT THE PATIENT DID NOT RESPOND TO THIS QUESTION. THE HOSPITAL REPORTED ON (B)(6) 2017 THAT THEY WERE CLOSING THEIR INVESTIGATION INTO THIS REPORTED INCIDENT WITH THE CONCLUSION OF UNKNOWN CAUSE SINCE THE HOSPITAL DID NOT DO ANYTHING DIFFERENT IN THIS CASE AND THAT PHILIPS HAD NOT SEEN THIS TYPE OF RESPONSE BEFORE. THE CUSTOMER WAS PROVIDED WITH THE INFORMATION THEY REQUESTED. THE DEVICE REMAINS AT THE CUSTOMER SITE. THERE IS NO EVIDENCE SUPPORTING THAT THE PHILIPS DEVICE OR ACCESSORIES MALFUNCTIONED OR CAUSED/CONTRIBUTED TO THE REPORTED RESPONSE. ACCESSORIES THAT WERE USED HAVE BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT, WHEN THE PATIENT AWOKE FROM ANESTHESIA, THE PATIENT COMPLAINED THAT THEIR THROAT AND CHEST WERE SORE. THE PATIENT CLAIMED THAT IT FELT LIKE SOMEONE HAD PERFORMED CPR ON THEM, EVEN THOUGH CPR WAS NOT REQUIRED DURING THE CASE. AFTER THE PATIENT WENT HOME, THE PATIENT CALLED THE HOSPITAL¿S RISK MANAGEMENT TEAM AND STATED THAT THEY HAD BRUISES (BLACK AND BLUE MARKS) ON THEIR STERNUM AREA, AROUND WHERE THE QUADTRODE ELECTRODE WAS PLACED. THE PATIENT REPORTEDLY WENT TO THEIR DOCTOR FOR THE ISSUE, BUT WE DO NOT KNOW AT THIS TIME WHAT THE DOCTOR SAID OR WHAT TREATMENT, IF ANY, WAS PRESCRIBED. THEREFORE, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190010 MWI PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 866185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1