|
Model Number N/A |
Device Problems
Pumping Stopped (1503); No Audible Prompt/Feedback (2282)
|
Patient Problem
Bradycardia (1751)
|
Event Date 11/10/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit by cleaning and performing preventative maintenance (pm) including all system checks, calibrations, electrical safety tests, and cleaning and operation check of the sensor module.All testing was performed per factory specifications; however, no anomalies or malfunction was found on the iabp unit.The iabp unit was cleared for clinical use and returned to the customer.
|
|
Event Description
|
It was reported during use, the alarm for the cardiosave intra-aortic balloon pump (iabp) did not sound even though the drive was stopped frequently while driving the iabp unit.Upon hearing the situation, the patient had bradycardia and the signal output from the bedside monitor, which is the signal output source, was unstable, so the ecg signal to the iabp was unstable (with or without r wave).It was reported that the iabp had been placed in semi-auto operation mode with the external monitor input by setting up an ecg source.It was later reported that the patient was in stable condition with the intra-aortic balloon (iab) frequency being set at 1:2.It was assumed that the iabp drive was temporarily stopped.However, the hospital took the equipment outage seriously, recognized it as a medical accident.Patient therapy was completed with no adverse consequence to the patient reported.It is unknown if the patient¿s injury is attributed to the iabp.Cardiosave iabp ecg (r iabp ggj iabp 11/12.This is an automated draft translation - if any uncertainty contact the local ssu immediately: complaint that the alarm did not sound even though the drive was stopped frequently while driving cardiosave.Upon hearing the situation, the patient had bradycardia and the signal output from the bedside monitor, which is the signal output source, was unstable, so the ecg signal to the iabp was unstable (with or without r wave).), so it was assumed that the iabp drive was temporarily stopped.However, the hospital took the equipment outage seriously, recognized it as a medical accident, and asked ggj to inspect the iabp drive unit.Inspection will be carried out on 11/12.
|
|
Event Description
|
It was reported during use, the alarm for the cardiosave intra-aortic balloon pump (iabp) did not sound even though the drive was stopped frequently while driving the iabp unit.Upon hearing the situation, the patient had bradycardia and the signal output from the bedside monitor, which is the signal output source, was unstable, so the ecg signal to the iabp was unstable (with or without r wave).It was reported that the iabp had been placed in semi-auto operation mode with the external monitor input by setting up an ecg source.It was later reported that the patient was in stable condition with the intra-aortic balloon (iab) frequency being set at 1:2.It was assumed that the iabp drive was temporarily stopped.However, the hospital took the equipment outage seriously, recognized it as a medical accident.Patient therapy was completed with no adverse consequence to the patient reported.It is unknown if the patient¿s injury is attributed to the iabp.
|
|
Search Alerts/Recalls
|
|
|