This supplemental correction filed to note that the initial mdr was to have been reported as a serious injury due to patient awareness and recall.Block b1, b2, and h1 updated accordingly.Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.
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There was no ge employee visit to this site, and therefore the repair is unknown.Ge healthcare product engineering performed an investigation of this event.Neither the cassette or vaporizer bay from the complaint were returned to ge healthcare (gehc) for testing.After testing with several available cassettes in the lab, engineering has not been able to reproduce a situation in which a cassette would be able to deliver agent and eject from the vaporizer bay without a user releasing the latch.The allegation that the machine did not alarm is unsubstantiated without device logs.The hospital risk manager gave the following statements: 1."the aisys cs2 is a new device and the staff are not familiar with it, as it is different than other devices used." 2."the event was caused by human error and the vendor came to re-educate staff and train new employees." 3."the user felt that the alarm was not prevalent and should be higher priority." removing the cassette during the case is expected in situations where agent runs low or to change agent types, so a higher priority alarm is considered to be a nuisance when the clinician is swapping cassettes.The patient said they were able to recall pain but denied any nightmares or trauma.The patient declined psychological evaluation and treatment.The root cause for this event is undetermined based on the available information.H3 other text : there was no ge employee visit to this site, and therefore the repair is unknown.Ge healthcare product engineering performed an investigation of this event.Neither the cassette or vaporizer bay from the complaint were returned to ge healthcare (gehc) for testing.After testing with several available cassettes in the lab, engineering has not been able to reproduce a situation in which a cassette would be able to deliver agent and eject from the vaporizer bay without a user releasing the latch.The allegation that the machine did not alarm is unsubstantiated without device logs.The hospital risk manager gave the following statements: 1."the aisys cs2 is a new device and the staff are not familiar with it, as it is different than other devices used." 2."the event was caused by human error and the vendor came to re-educate staff and train new employees." 3."the user felt that the alarm was not prevalent and should be higher priority." removing the cassette during the case is expected in situations where agent runs low or to change agent types, so a higher priority alarm is considered to be a nuisance when the clinician is swapping cassettes.The patient said they were able to recall pain but denied any nightmares or trauma.The patient declined psychological evaluation and treatment.The root cause for this event is undetermined based on the available information.
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