BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSION PATIENT MONITOR (MR400)

    MDR report key: 12302469 · Received August 10, 2021

    Report

    Report Number
    1051786-2021-10044
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    July 30, 2021
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    UDI-DI
    00884838039131
    PMA / PMN Number
    K152330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS RESPONSE SERVICE ENGINEER (RSE) SPOKE TO A REPRESENTATIVE OF KETTERING MEDICAL CENTER (KMC). KMC WAS ADVISED THAT THE ADHESIVE FOR THE PHILIPS EKG ELECTRODE PAD WAS ACRYLIC. SEVERAL ATTEMPTS WERE MADE BY PHILIPS TO ACQUIRE ADDITIONAL INFORMATION RELATED TO THE PATIENT¿S CONDITION, AS WELL AS INFORMATION RELATED TO THE MRI PROCEDURE THAT THE PATIENT UNDERWENT. A RESPONSE WAS RECEIVED FROM KMC WHICH INDICATED THAT ON (B)(6) 2021, A PATIENT PRESENTED AT KMC FACILITY FOR AN MRI PROCEDURE FOR UNSPECIFIED TESTING. KMC CONFIRMED THAT THE ELECTRODES USED IN THIS EVENT WERE MRI NONMAGNETIC EKG QUADTRODE ELECTRODES AND THAT THE EKG MONITOR DEVICE CORRESPONDED WITH A PHILIPS PART NUMBER 989803162051, ANESTHETIC OXYGEN (O2) SENSOR. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE TO PHILIPS BY KMC REGARDING THE PATIENT¿S STATE AFTER THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOLLOWING THE SCHEDULED MRI PROCEDURE. NO LASTING EFFECTS OF THE EVENT WERE REPORTED TO PHILIPS DESPITE SEVERAL ATTEMPTS TO PROCURE THIS INFORMATION FROM KMC. SEVERAL ATTEMPTS WERE MADE TO SECURE INFORMATION RELATED TO THE PHILIPS ELECTRODES THAT WERE UTILIZED DURING THE MRI PROCEDURE. KMC CONFIRMED THAT THE ELECTRODES HAD BEEN DISPOSED OF THE DAY THAT THE TESTING TOOK PLACE AND WERE NOT AVAILABLE TO PHILIPS TO AID IN THE INVESTIGATION OF THIS EVENT. PHILIPS PROVIDED THE ELECTRODE ADHESIVE INGREDIENTS INFORMATION TO KMC. AS A RESOLUTION TO THE CUSTOMER REQUEST. AS THE CUSTOMER DID NOT REPORT EXPERIENCING ANY QUALITY DEFICIENCIES WITH THE PRODUCTS THAT WERE IN SERVICE AT THE FACILITY, WE WILL CONSIDER THAT THE CUSTOMER RESOLVED THE ISSUE USING THE INFORMATION PROVIDED BY PHILIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON JULY 30, 2021, A REPRESENTATIVE FROM KETTERING MEDICAL CENTER CONTACTED PHILIPS AND REQUESTED INFORMATION ON THE INGREDIENTS OF THE ADHESIVE FOR THE EKG ELECTRODE PADS. IT WAS REPORTED THAT ¿DURING MRI, PT THAT PADS WERE USED ON, DEVELOPED AN ALLERGIC REACTION ON SITE TO ADHESIVE (BLISTERING AND REDNESS). PT WAS NOT WEARING ANY LOTION OR FRAGRANCE AT THE TIME.¿ AS THE EVENT WAS REPORTABLE TO A REGULATORY AUTHORITY, AN INVESTIGATION WAS REQUIRED. ADDITIONAL INFORMATION WAS LATER PROVIDED BY KETTERING MEDICAL CENTER, WHICH ASSERTED THAT THE PATIENT COMPLAINED ABOUT ¿HAVING A HARD TIME SWALLOWING, CHEST PAIN¿ AND FEELING ¿SLIGHTLY OUT OF BREATH¿ DURING THE MRI PROCEDURE. THE PATIENT WAS CONCERNED ABOUT HAVING AN ANAPHYLACTIC REACTION AND PRESENTED TO THE EMERGENCY DEPARTMENT FOLLOWING THE COMPLETION OF THE MRI PROCEDURE. SHE WAS DIAGNOSED WITH AN ALLERGIC REACTION AND PRESCRIBED A 4MG MEDROL DOSE PACK TO RESOLVE THE ALLEGED ALLERGIC REACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN MRI, THE PATIENT THAT THE EKG ELECTRODE PADS WERE USED ON, DEVELOPED AN ALLERGIC REACTION ON SITE TO THE ADHESIVE (BLISTERING AND REDNESS). ADDITIONAL INFORMATION RECEIVED INDICATED THAT, DURING THE MRI THE PATIENT ALLEGED SHE HAD A HARD TIME SWALLOWING, CHEST PAIN, AND FELT SLIGHTLY OUT OF BREATH. AFTER THE MRI SCAN WAS COMPLETED AND PATIENT REMOVED THE PADS, SHE NOTICED THE AREA WAS VERY RED WHERE THE PATCH WAS PLACED WITH SOME SMALL BLISTERS. THE PATIENT WAS CONCERNED ABOUT HAVING AN ANAPHYLACTIC REACTION, SO SHE PRESENTED TO THE EMERGENCY DEPARTMENT AFTER HER MRI WAS COMPLETED. THE PATIENT WAS DIAGNOSED WITH AN ALLERGIC REACTION AND PRESCRIBED A MEDROL DOSE PACK 4MG DOSE PACK. THERE WAS NO LASTING IMPACT TO THE PATIENT REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200161 EXPRESSION PATIENT MONITOR (MR400) EXPRESSION PATIENT MONITOR (MR400) MWI INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS 866185 00884838039131

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization