BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS HI

    MDR report key: 3002302 · Received March 13, 2013

    Report

    Report Number
    2910081-2013-01454
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' CUSTOMER SERVICE ENGINEER AND THE CUSTOMER AFFIXED THE SUPPORT PLATE FOR THE CEILING HAND CONTROL TO THE CEILING BY REPLACING THE SCREWS THAT HAD LOOSENED, AND ADDED FOUR NEW HOLES AND SCREWS TO MAKE SURE THERE IS NO ROTATION DURING USE. THERE HAVE BEEN NO OTHER REPORTS OF THE ISSUE, AND THE SYSTEM HAS BEEN OPERATIONAL SINCE THE TIME OF THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED SIEMENS ON (B)(6) 2013 THAT THE SUPPORT PLATE AND THE CEILING HANDCONTROL DROPPED DOWN SUDDENLY AFTER THE SCREWS THAT FIXED THE SUPPORT FOR THE CEILING HANDCONTROL HAD LOOSENED OVER AN EIGHT YEARS TIME SPAN SINCE INSTALLATION. REPORTEDLY, A TECHNICIAN SUSTAINED "LIGHT INJURIES" THAT DID NOT REQUIRE MEDICAL INTERVENTION. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105470 PRIMUS HI ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 04504200

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPPORT FOR CIELING HAND CONTROL