It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was generating error codes 2 and 55.There was no patient involvement, and no adverse event reported.
|
Updated fields: b4, e1(site country, event site postal code - 75013), g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings and investigation conclusions), h10, h11.Corrected fields: h6(component codes).Additional information: (b)(4).
|