[3908890]
On (b)(6) 2006, i, (b)(4), technical support and quality regulatory manager of tingle x-ray, llc, rec'd a call from (b)(4), a biomedical engineer, employed by (b)(4). According to (b)(6), phn works for several networked hospitals within (b)(6). This event began when (b)(6) was called for svc on the x-ray generator listed above. The svc call was from (b)(6). The call was rec'd by (b)(6) on the (b)(6) 2013. Brian stated when he arrived at providence on the (b)(6), the x-ray unit was not showing the mas display and the magnetic locks throughout the x-ray room were not powered. After checking a few things himself he called into txr for technical support, i answered the call. After taking all of the equipment info from brian, i asked him to measure several points within the generator. He complied. During the support call i determined the 24vac power supply (transformer) within the generator was not working and needed replacement. Quoted (b)(6) pn 12756b. Brian proceeded to explain to me, that when the locks were no longer powered by the generator in the room, the tube-stand fell on a pt. I immediately inquired if the pt had been checked by a physician, if injury had occurred, and if an mdr report had been filed. (b)(6) stated, "yes, the pt was given a full exam and did not incur any physical injury. " he also stated the hospital usually filed these types of reports. I replied, that since i was aware of the situation, i was also required to file a report and would assist the info collected. I further asked (b)(6) for the info located on the certified labeling of the tube-stand that fell on the pt. Brian stated the tube-stand was a very old model and that he could not locate the label. He could only determine its mfr, which was continental x-ray. According to my own internet search during our call, it was determined continental sold in 1996. (b)(6) further explained the hospital had already decided they would repair the generator but was going to remove the tube-stand from the facility. (b)(6) and i spoke about proper counterbalancing of the tube-stand. Specifically, when a back-up safety lock disengages, whether is it manually disengaged by the user, disengaged due to a power outage, or even a component failure, the tube, collimator and handlebar assembly should never free-fall or hoist up suddenly. If the tube-stand is counterbalanced properly the weight is evenly distributed and can be moved with only one hand. (b)(6) understood this. I asked (b)(6) if he knew, or had record of, who installed the original room of equipment. He did not but said he would check with the hospital. After speaking with (b)(6), i ran a trace on the serial number of the generator and found this device was originally sold through a (b)(4). I called and spoke to the owner, (b)(4), to inquire about the installation of the generator and the existing equipment in the room. (b)(4) stated, "when the hospital called us, the old continental generator was not working, not functional. We were hired to remove and replace the generator only. The remainder of the original equipment remained at the facility. " (b)(4) then provided me with the info he had on record, the original name of the hospital and address where he installed the equipment. The name of the hospital had changed from (b)(6), but the address is the same. The equipment has not been moved from its original site of installation. When i asked bruce if he was aware of the original mfr of the equipment, he also did not know, or have any record of, the original installer. I also advised (b)(4) that i would be filing a mdr report. Tube-stands and wall-stands should be counterbalanced during installation by the dealer/seller/installer of the equipment. Since we cannot contact or determine the original mfr, we feel it is our responsibility to report this matter with the info we are ware of. This concludes (b)(4) investigation. If you have any questions or concerns, please contact me anytime. Mfr name, city and state: continental x-ray, unk address. Out of business since 1996.
Patient Sequence No: 1, Text Type: D, B5