Model Number 0998-00-3023-55 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The full name of the event site in initial reporter was shortened due to field character limit; the full name is (b)(6).The full name of the event site address in initial reporter was shortened due to field character limit; the full name is (b)(6).Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse was able to verify the alarms in the iabp¿s diagnostic error log.The main board and datasettes were removed from the iabp unit and installed in another iabp unit.The fse determined that the main board was the fault origin.The main board and datasettes were then returned to the defective device.Unrelated to the reported issue, it was also observed that the safety disk change time of the device had passed.Due to the software version change, the fses recommended to supply the main board together with the data sets.The device has not been repaired at this time and remains in a faulty state.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) gave electrical test fail code 35 alert.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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The customer was presented with a cost estimate for repairs; however, no response has been received at this time.The iabp unit remains faulty.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) generated an electrical test fail code #35 alert.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Search Alerts/Recalls
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