BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWI

    MDR report key: 8194522 · Received December 24, 2018

    Report

    Report Number
    1051786-2018-00059
    Event Type
    Malfunction
    Date Received
    December 24, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 21, 2018
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K152330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: UPDATING COMPLAINT FROM SERIOUS INJURY TO NON ADVERSE EVENT BASED ON ADDITIONAL INFORMATION FROM THE CUSTOMER, WHO INDICATED THAT THE PATIENT DID NOT REQUIRE ANY TREATMENT AS A RESULT OF THE INCIDENT. 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. THE INITIAL INFORMATION RECEIVED ABOUT THIS INCIDENT INDICATED THAT THERE WAS PATIENT HARM, BUT THE INFORMATION RECEIVED DID NOT INDICATE WHAT KIND OF TREATMENT (IF ANY) THE PATIENT REQUIRED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THEY WERE NOTIFIED BY THEIR CUSTOMER THAT ONE OF THEIR PATIENTS MAY HAVE BEEN "BURNED" BY THE STANDARD ECG CABLE. THE CUSTOMER THOUGHT THAT AT THIS TIME, IT HAS PROBABLY FAILED. PHILIPS IS CONSIDERING THAT THE CUSTOMER MEANS THE CHECK AND CROSS CHECK FAILED, BUT IS CONFIRMING THIS INFORMATION. THERE WERE NO REPORTED BLISTERS AND THE SKIN WAS DESCRIBED AS "JUST RED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032711 MWI PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 866185

    Patients

    Seq Age Sex Outcome Treatment
    1