It was reported by health (b)(6) that medical device report was submitted by a hospital for a m2000 wand and m102 generator.Search was performed on health (b)(6) online database for incident reports.The following events were coded: convulsion seizure, computer software problem, patient-device incompatibility, communication or transmission problem, interrogation problem, testing of actual/suspected device, configuration issue, incorrect data definition, unintended use error caused or contributed to the event.It was noted the event had potential for death/injury.Based on the context of software issue caused by user error leading to increased seizures, the event was most likely a faulted diagnostics.It is known that the m102 generator is susceptible to settings changes if diagnostics tests are interrupted.This happens because on m102 generators, diagnostics tests reprogram the patient's settings to run the diagnostic test and then will reprogram the generator, back to intended settings, so if the diagnostics test is interrupted, then settings may not be corrected to intended settings if a final interrogation prior to ending a programming session to check settings is not performed as recommended, the patient may be left at this settings change.No further relevant information has been received to date.
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