Testing of actual/suspected device (10/213): a getinge field service engineer (fse) evaluated the iabp unit for the overheat error, but was unable to reproduce.It was seen in diagnostic mode, when warmed up in the compressor output mode, that the temperature went from 61 degrees to 46 and went back sporadically.To fix the issue, the fse replaced the front end processor board and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
|
Updated fields: b4, g2, g3, g6, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: b5, e1(event site email), e2, e3, g1(contact person), h6(clinical code).*initial reporter telephone: (b)(6).
|