BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILETT XP

    MDR report key: 4961796 · Received July 31, 2015

    Report

    Report Number
    2240869-2015-03746
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SIEMENS GMBH HENKESSTRASSE 127
    Product Code
    IZL
    PMA / PMN Number
    K827929
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INVESTIGATED IN DETAIL AND AN ONSITE VISIT FOR INVESTIGATION WAS PERFORMED. IT IS CONCLUDED THAT THE ROOT CAUSE FOR THE REPORTED EVENT WAS AN EXTERNAL INFLUENCE ON THE MOBILETT XP, WHEN A CERTAIN AMOUNT OF LIQUID WAS POURED ON AND INTO THE SYSTEM. THE LIQUID CAUSED A SHORT CIRCUIT OF THE ENERGY STORING CAPACITORS. ACCORDING TO THE HOSPITAL PERSONNEL, A LEAD APRON WAS CLEANED WITH SOAPED LIQUID ON THE MOBILETT XP SYSTEM. THE APRON WAS AFTERWARDS HUNG OVER THE EQUIPMENT. THE HOSPITAL STAFF ALSO MENTIONED THAT A PUDDLE OF LIQUID WAS NOTICED BETWEEN THE MOBILETT XP SYSTEM AND A RADIOLOGY TABLE OF A NON-SIEMENS SUPPLIER (PRIMAX) THAT WAS ALSO INSTALLED IN THE EXAM ROOM. THE MOBILETT XP WAS PLUGGED INTO THE MAIN POWER SUPPLY SOURCE AND WAS SWITCHED ON DURING THE REPORTED EVENT. ACCORDING TO THE LOCAL SIEMENS SERVICE SUPPORT, THE RESIDUAL CURRENT CIRCUIT BREAKER OF THE HOSPITAL'S LINE POWER WAS TRIGGERED AND THE EQUIPMENT WAS CUT OFF FROM THE LINE POWER. IT COULD NOT BE DETERMINED, WHY THE OPERATOR HAD SUFFERED FROM AN ELECTRICAL SHOCK WHEN TOUCHING THE CONTROL PANEL OF THE PRIMAX SYSTEM. HOWEVER, IT IS ASSUMED THAT THE LIQUID ON THE FLOOR AND THE LIQUID IN THE MOBILETT SYSTEM MIGHT HAVE HAD STRONG IMPACT. THE OPERATOR MANUAL CONTAINS CAUTIONS IN REGARDS TO LIQUIDS THAT MAY PENETRATE THE INTERIOR OF THE UNIT AND BEAR THE RISK OF ELECTRICAL SHOCK AND/OR DAMAGE TO THE SYSTEM (SEE SPR8-230.621.01.06.02, PAGE 84). THE MOBILETT XP SYSTEM IS DESIGNED ACCORDING TO IEC 60601-1 AND SEVERAL SAFETY PROTECTIONS ARE IMPLEMENTED TO THE SYSTEM. THE PROTECTIVE MEASURES OPERATED AS FORESEEN UNDER THIS SPECIAL ERROR CONDITION. SIEMENS HAS REQUESTED FOR THE SYSTEM TO BE RETURNED FOR INVESTIGATION BUT THESE REQUESTS WERE DENIED BY THE CUSTOMER. THE CUSTOMER WAS ADVISED NOT TO USE THE SYSTEM UNTIL THE SYSTEM USE IS CLEARED BY THE FACTORY. AFTER AN ONSITE VISIT BY SIEMENS EXPERTS THE INTERNAL CABLING WAS DISCONNECTED AND REMAINED UNPLUGGED, SO THAT THE CONCERNED UNIT CANNOT BE USED. THIS REPORT WAS SUBMITTED FEBRUARY 29, 2016.

    Additional Manufacturer Narrative · 1

    A SIEMENS ENGINEER INSPECTED THE UNIT AFTER THE REPORTED INCIDENT; AN ON-SITE VISIT BY SIEMENS EXPERTS WAS ALSO INITIATED. THE INSPECTION OF THE DEVICE SHOWED REMAINS OF LIQUID INSIDE THE MOBILETT XP UNIT. A PUDDLE OF LIQUID WAS ALSO PRESENT BETWEEN THE TWO MACHINES; LIQUID WAS ALSO FOUND IN THE CHASSIS UNDER THE CAPACITOR BOARD. THE GROUNDING OF THE EQUIPMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. MARKS OF ELECTRICAL DISCHARGE WERE IDENTIFIED WITHIN THE SYSTEM. THE FLOOR IN THE EXAM ROOM WAS MEASURED AS NON-CONDUCTIVE. THE SYSTEM WAS TAKEN OUT OF OPERATION AND THE CUSTOMER WAS INFORMED NOT TO USE IT UNTIL FURTHER NOTICE. THE INVESTIGATION OF THE REPORTED ISSUE IS ON-GOING. THE SYSTEM WAS REQUESTED TO BE RETURNED TO SIEMENS FOR FURTHER INVESTIGATION. THE CUSTOMER CURRENTLY REFUSED TO RETURN THE UNIT. THE PRIMAX SALES ENGINEER WAS CONTACTED. SHE CONFIRMED THAT NO DEFECTS (ELECTRICAL OR MECHANICAL) WERE FOUND ON THE PRIMAX SYSTEM. SIEMENS EQUIPMENT IS DESIGNED ACCORDING TO (B)(6) STANDARDS AND SAFETY PROTECTION IS IMPLEMENTED TO PROTECT OPERATORS AND PATIENTS FROM VOLTAGE. THIS REPORT WAS SUBMITTED (B)(6) 2015. CUSTOMER'S ADDRESS: HOSPITAL (B)(6).

    Description of Event or Problem · 1

    SIEMENS MOBILETTE XP SYSTEM WAS LOCATED IN THE SAME EXAM ROOM WITH PRIMAX RADIOLOGY TABLE. THE DEVICES WERE LOCATED APPROXIMATELY 2 METERS AWAY FROM EACH OTHER. A WET LEAD APRON WAS PLACED ON THE MOBILETT XP TABLE; THE UNIT WAS THEN PLUGGED IN AND TURNED ON BY TWO TECHNICIANS PRESENT IN THE EXAM ROOM. A LOUD BANG WAS HEARD IN THE EXAM ROOM AFTER THE MOBILETT UNIT WAS SWITCHED ON. SIEMENS ALSO BECAME AWARE THAT THE FLOOR IN THE EXAM ROOM HAD BEEN WASHED WITH SOAPY WATER PRIOR TO THE INCIDENT. AS A RESULT OF THE INCIDENT A RADIOLOGY OPERATOR WAS ELECTROCUTED WHILE PLACING HER FINGER ON THE COMMAND BOARD OF THE PRIMAX TABLE DURING ARCING. THE OPERATOR WAS TAKEN TO THE EMERGENCY ROOM, CARDIOLOGY AND NEUROLOGY DEPARTMENTS FOR EVALUATION. SHE LOST SENSITIVITY IN HER RIGHT ARM BUT WAS DISCHARGED ON SICK LEAVE. ANOTHER HOSPITAL STAFF MEMBER PRESENT IN THE ROOM DURING THE INCIDENT WAS ELECTROCUTED AS WELL. THE SECOND OPERATOR WAS MONITORED WITH EKG FOR SEVERAL HOURS AND LATER RELEASED. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498836 MOBILETT XP MOBILE X-RAY SYSTEM IZL SIEMENS GMBH HENKESSTRASSE 127 1818363 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other