The Case of the Medical Equipment Malpractice
Synopsis:
If any case demonstrates that “Truth is in the Details” this is it.
Background:
A medical X-ray machine valued at $500k suffered repetitive and identical failures, commencing with what was claimed to be an internal fire. The manufacturer’s technicians determined that the failures were due to a massive fault deep within the machine and that the machine was a total loss.
Assignment:
TI was requested to determine the cause of failure. The original failed component was a transformer and it and multiple replacement transformers that had failed on installation were obtained. The transformers were subjected to extensive laboratory testing and it was found that the initially failed transformer had failed as the result of a normal end-of-life failure. While it was claimed that a fire had broken out as a result of the initial failure, it was conclusively demonstrated that even though there was “smoke” associated with decomposition of insulating materials, there was no actual flame emitted in the failure. Laboratory testing determined that even though the original failed transformer and all replacement transformers had identical part numbers with identical engineering revision levels, there had been an unrecorded engineering change between the original component and all of the replacements. Laboratory testing demonstrated the correct manner in which to install the revised parts so as to avoid additional failures. The X-ray machine was then successfully repaired. Ultimately, investigation found that the machine was covered under an existing maintenance contract and thus the manufacturer covered all costs of repairs at no cost to the insured or insurer.
