BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX PRO

    MDR report key: 5964326 · Received September 20, 2016

    Report

    Report Number
    2124823-2016-00006
    Event Type
    Injury
    Date Received
    September 20, 2016
    Date of Event
    June 15, 2016
    Report Date
    November 7, 2016
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    PMA / PMN Number
    K032369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED TO GEHC FOR EVALUATION HOWEVER THE TRANSMITTER BATTERIES WERE NOT AVAILABLE FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT SHOW ANY INDICATION OF BURN MARKS OR PLASTIC DEFORMATION DUE TO EXCESS HEAT DISSIPATION. THERE WAS NO SIGNS OF FLUID INGRESS OR OTHER PHYSICAL DAMAGE. TESTING WAS PERFORMED UNDER NORMAL USE CONDITIONS TO ENSURE MAXIMUM SURFACE TEMPERATURE DID NOT EXCEED 41 DEGREES C (PER IEC60601-1 CLAUSE 42.3). THE MEASURED TEMPERATURES OF THE TRANSMITTER CASE AT AMBIENT ROOM AND BODY TEMPERATURE DID NOT EXCEED 38 DEGREES C. PRIOR TO SENDING THE DEVICE TO GEHC, THE HOSPITAL BIOMEDICAL TECHNICIAN WORE THE DEVICE FOR 4 DAYS DURING WORK HOURS AND NO ISSUES WERE IDENTIFIED. IN CONCLUSION, GEHC ENGINEERING WAS UNABLE TO DUPLICATE THE REPORTED ISSUE NOR DETERMINE THE ROOT CAUSE BASED ON VISUAL INSPECTION AND ELECTRICAL AND TEMPERATURE TESTING PERFORMED. THE TRANSMITTER WAS FOUND TO BE PERFORMING TO SPECIFICATIONS AND THERE WAS NO EVIDENCE THE TRANSMITTER MALFUNCTIONED RESULTING IN THE ALLEGED PATIENT BURN.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SUFFERED A BURN TO HIS RIGHT THIGH AFTER SLEEPING ON THE TELEMETRY TRANSMITTER FOR SEVERAL HOURS. THE INVESTIGATION IS ON-GOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614618 APEX PRO MONITOR, PHYSIOLOGICAL, PATIENT MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. APRO-CH-US-ENG-AHA- RT913494292GA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other