BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT DATA MODULE

    MDR report key: 4712596 · Received April 21, 2015

    Report

    Report Number
    2124823-2015-00009
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Report Date
    April 2, 2015
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K071073
    Removal / Correction Number
    Z-0648-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT OBTAINED. DATE OF INCIDENT IS UNKNOWN. THE TOP COVER WAS NOT RETURNED FOR EVALUATION HOWEVER, PHOTOS WERE PROVIDED. ENGINEERING REVIEWED THE PHOTOS AND FOUND A HEAVY AMOUNT OF FLUID TRACES ON THE TOP COVER. IT IS BELIEVED THAT CLEANING FLUIDS DRIBBLED INTO THE PATIENT DATA MODULE (PDM) THROUGH THE TOP COVER. AFTER ENTERING THE TOP COVER, CLEANING FLUID EVENTUALLY TOUCHED THE EXPANSION PRINTED CIRCUIT BOARD AND THE LIVE BATTERY CONNECTOR PINS. THE CLEANING PRECAUTIONS LISTED IN SECTION 5 MAINTENANCE OF THE 2030047-011A SOFTWARE VERSION 2 PDM SERVICE MANUAL, NOTES 4 & 6 ON PAGE 5-3 CLEARLY DESCRIBE HOW TO KEEP CLEANING FLUIDS OUT OF THE PRODUCT. FLUIDS ARE NEVER TO BE POURED OR SPRAYED ON MEDICAL EQUIPMENT OR BE PERMITTED TO SEEP INTO CONNECTIONS OR OPENINGS. BASED ON THE INVESTIGATION AND SUPPORTING EVIDENCE, THE CLEANING FLUIDS DRIBBLING INTO THE PDM THROUGH THE TOP COVER IS THE ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BURNT COMPONENTS INSIDE THE PATIENT DATA MODULE. NO REPORT OF SMOKE OR FLAME. NO PATIENT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261818 PATIENT DATA MODULE PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1