BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEST STAND

    MDR report key: 971522 · Received December 18, 2007

    Report

    Report Number
    1221300-2007-00007
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Date of Event
    October 29, 2007
    Report Date
    December 11, 2007
    Manufacturer
    TREX MEDICAL INC
    Product Code
    IYB
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOLOGIC CONTACTED THE RADIOLOGICAL TECH. THE RADIOLOGICAL TECH TOLD US THAT THE INJURY TO THE PT RELATED TO THIS INCIDENT WAS VERY MINOR, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE COULD NOT BE REPAIRED, AS PARTS ARE NO LONGER AVAILABLE. THE PT SUPPORT DEVICE WAS REMOVED FROM SERVICE. TREX MEDICAL IS NO LONGER IN BUSINESS, AND THE DEVICE IS NO LONGER MANUFACTURED.

    Description of Event or Problem · 1

    HOLOGIC RECEIVED A REPORT IN 2007 FROM PHILIPS, WHO FUNCTIONS AS A SERVICE PROVIDER FOR THE HOSP THAT OWNS THE UNIT. THE REPORT STATED THAT DURING POSITIONING OF A PT FOR A CHEST EXAM, THE RADIATION TECHNOLOGIST ADJUSTED THE PT SUPPORT DEVICE, AND THE DEVICE RELEASED BY ITSELF AND STRUCK THE PT ON THE HEAD. THE SERVICE ENGINEER FROM PHILIPS FOUND BROKEN TENSION SPRING IN THE SUPPORT DEVICE. SINCE THIS PROD IS NO LONGER SUPPORTED, AND PARTS ARE NOT AVAILABLE TO REPAIR THE EQUIPMENT, THE SERVICE ENGINEER REMOVED THE PT SUPPORT DEVICE FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEST STAND X-RAY DEVICE IYB TREX MEDICAL INC C-9800R

    Patients

    Seq Age Sex Outcome Treatment
    1 YR