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Model Number 0998-00-3013-53 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested, and we will report accordingly if it becomes available.(b)(6).
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) shutdown.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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A getinge authorized distributor's field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.After maintenance test, it was confirmed that the reported issue was caused by a battery problem; however, after the fse had a discussion with the customer in regards to the repair, it was decided by the customer that they would not buy the part.The iabp was then released to the customer, but not cleared for clinical service.
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Event Description
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It was reported that before use, the cs100 intra-aortic balloon pump (iabp) shutdown.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6, h10, h11.Corrected fields: h4.A getinge service representative reported that the customer has repaired the iabp and the equipment has been returned.A supplemental report will be submitted if additional information is provided.
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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) has confirmed that the customer has agreed to replace the battery.The battery assembly was replaced and after replacement, all safety, functionality, and calibration checks were performed.All tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.Historical data analysis: (4109/102) 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: (4110/102) the overall 12 month product complaint trend data for the period (dec 2019 through nov 2020) was reviewed.There were no triggers identified for the review period.Analysis of production: (3331/102) the device history records 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.
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Search Alerts/Recalls
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