BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAVIEW SL COMMAND MODULE

    MDR report key: 2942043 · Received February 4, 2013

    Report

    Report Number
    3023361-2013-00016
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 21, 2012
    Report Date
    February 4, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K972502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REVIEWED HOW THE COMMAND MODULE WAS BEING USED. THE MONITOR WAS MOUNTED ABOVE THE DISPLAY AND IS AT A HEIGHT THAT A PERSON WOULD HAVE TO REACH ABOVE THEIR HEADS IN ORDER TO CORRECTLY ALIGN THE MODULE TO THE MONITOR. THE OVERHEAD REACH CAUSES AN ANGLE WHEN TRYING TO INSERT THE MODULE AND THIS ANGLE WILL ADD RESISTANCE WHEN PUSHING THE MODULE INTO PLACE. THE REPORTED EVENT WAS THE RESULT OF THE NURSE USING MORE FORCE THAN USUAL TO INSERT THE COMMAND MODULE INTO THE MONITOR. WHEN THE MODULE SNAPPED INTO PLACE THE NURSES FINGER WAS PINCHED AND INADVERTENTLY LACERATED AS A RESULT. THE NURSE WAS THEN ADMINISTERED A TETANUS SHOT. THE FIELD SERVICE ENGINEER RECOMMENDED THAT THE HOSPITAL STAFF LOWER THE MODULE HOUSING TO AN ACCESSIBLE HEIGHT. THIS MINOR INJURY WAS ACCIDENTAL IN NATURE AND NOT A FAILURE OF THE PRODUCT TO MEET SPECIFICATIONS. THERE HAVE BEEN NO OTHER REPORTS OF LACERATED FINGERS ASSOCIATED WITH USING THE 91496 COMMAND MODULE. SPACELABS CONSIDERS THIS ISSUE CLOSED. NOT A PRODUCT MALFUNCTION - USER ERROR.

    Description of Event or Problem · 1

    STAFF NURSE WAS INSERTING THE 91496 COMMAND MODULE INTO THE XPREZZON MONITOR WHEN THERE WAS SOME RESISTANCE, THE NURSE APPLIED ADDITIONAL FORCE AND CUT HER FINGER ON THE MONITOR WHEN THE MODULE SLID INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45934 ULTRAVIEW SL COMMAND MODULE MULTI-PARAMETER MODULE 91496 DSI SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention