Model Number 0998-00-3013-55 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2020 |
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) had a system failure.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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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) had a system failure.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 field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The fse observed the iabp up to 2 to 3 hours on running mode with his calibration balloon, but could not duplicate the issue.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
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Manufacturer Narrative
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Updated fields: h6 (evaluation method codes).Corrected fields: d4 (catalog#, unique identifier (udi) #), d5, h6 (patient codes).
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Event Description
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It was reported that the cs100 intra-aortic balloon pump (iabp) had a system failure.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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Event Description
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N/a.
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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.
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Search Alerts/Recalls
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