BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGENCY, INC

    MDR report key: 164459 · Received April 23, 1998

    Report

    Report Number
    MW1013630
    Event Type
    Malfunction
    Date Received
    April 23, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 10, 1998
    Manufacturer
    PROGENY, INC.
    Product Code
    IZX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE POSITIONING THE COLLIMATOR AND SHUTTER DEVICE, COLLIMATOR AND SHUTTER DEVICE DISCONNECTED FROM THE X-RAY TUBE ASSEMBLY. THE COLLIMATOR AND SHUTTER DEVICE DROPPED ONTO THE PT'S HIP AREA. PT REC'D BRUISING TO THE HIP. SVC CO WAS CONTACTED TO INSPECT AND REPAIR THE UNIT. UPON INSPECTION IT WAS FOUND THE A SCREW WAS LOOSE ON THE BAND WHICH SECURES THE COLLIMATOR AND SHUTTER DEVICE TO THE X-RAY TUBE ASSEMBLY. THIS LOOSE SCREW ALLOWED THE SAFETY CATCH TO RELEASE WHICH RESULTED IN THE ABOVE MENTIONED INCIDENT. THE BAND HAD BEEN REPLACED IN DECEMBER 1997 OR JANUARY 1998. THIS BAND WAS NOT THE BAND ORIGINALLY INSTALLED ON THE EQUIPMENT. CO ADVISED THAT THE BAND APPEARED TO HAVE A DESIGN DEFECT. TO PREVENT FUTURE OCCURRENCES, THE SCREW ON THESE DEVICES WILL HAVE "LOCK TIGHT" PLACE ON THE SCREW. A SCHEDULE FOR BIOMEDICAL ENGINEERING TO INSPECT THE DEVICE HAS BEEN IMPLEMENTED. THIS WILL AUGMENT THE INSPECTIONS DONE BY THE SVC REP. DAILY CHECKS OF THE DEVICE WILL BE DONE BY THE TECHNICIANS IN RADIOLOGICAL SVCS. PROBLEMS WILL BE REPORTED AND CHECKS DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENCY, INC COLLIMATOR & SHUTTER DEVICE IZX PROGENY, INC. 93741 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other