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Model Number 0998-00-3023-53 |
Device Problem
No Display/Image (1183)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and cleaned the coiled cable contacts.The display connections were also checked but the fse was unable to duplicate the customer's reported issue.No problems were observed.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.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 use on a patient, the screen for the cs300 intra- aortic balloon pump (iabp) went blank.It was later reported that the display would go blank but came back on and the iabp unit did not stop assisting.The iabp unit was swapped with another iabp unit but the patient passed away.The customer has not attributed the patient's death to the reported issue.The associated intra-aortic balloon (iab) has been reported under medwatch report # 2248146-2021-00486.Screen stude blank while on patient.Screen stude blank while on patient.Patient passed due to switching equip over.Po: (b)(4) all information given by contact person, (b)(6).(b)(4).Cs300,english,110v,domestic.(b)(4).
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Event Description
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It was reported that during use on a patient, the screen for the cs300 intra- aortic balloon pump (iabp) went blank.It was later reported that the display would go blank but came back on and the iabp unit did not stop assisting.The iabp unit was swapped with another iabp unit to continue therapy without issue.There was no patient harm and no adverse event was 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 (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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