Model Number 0998-00-3013-53 |
Device Problems
Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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After diagnosis performed by a getinge field service engineer (fse), a problem with display controller pcb was found.The fse informed that first the display controller pcb needs to be replaced and once display gets on, the stm will be able to diagnose further.The final service report was not completed yet.A supplemental report will be submitted when final service report becomes available.
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Event Description
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It was reported by the customer that display was not working and continue beeping.The error sound occurred in the cardiosave intra-aortic balloon pump (iabp).It is unknown under which circumstances this 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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It was reported that the hospital's biomedical engineer repaired locally display controller pcb ,video recover pcb, and key control pcb.A getinge field service engineer (fse) was notified over phone call that the iabp is functioning properly.
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Event Description
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It was reported that during customer's routine check, display was not working and continue beeping.The error sound occurred in the cardiosave intra-aortic balloon pump (iabp).There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111) a getinge fse confirmed via telephone that the unit was returned to clinical use.
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Search Alerts/Recalls
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