The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.The customer did not provide the model name/number or serial number of the iabp involved.However, a getinge representative has advised that the customer has not alleged a malfunction of the iabp, no repairs are needed and that the iabp is working well.If additional information is provided, a supplemental report will be provided.No reported malfunction.
|
It was reported that during cardiosave intra-aortic balloon pump (iabp) therapy, there was a possible insertion in false-lumen, and entrapment of the sensation plus 50cc intra-aortic balloon catheter (iabc) in the patient.However, at the time of this report, the patient was alive.There was no reported malfunction of the iabp, and the facility has advised that the patient's injury is not attributed to the iabp.Refer to mfg report # 2248146-2019-00640 for information on the involved iabc.
|