Model Number N/A |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested.A supplemental report will be sent upon receiving this information.The full name of the event site is (b)(6).
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Event Description
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It was reported that during inspection by a getinge field service engineer (fse) service in getinge japan office, the touch panel of the cardiosave intra-aortic balloon pump (iabp) did not respond.There was no patient involvement and no adverse event was reported.
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Manufacturer Narrative
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To address the issue, the getinge field service engineer (fse) opted to replace the touchscreen assembly.The fse confirmed the improvement of symptoms after the repair was completed.Inspection was performed and the iabp operated to specifications.The iabp unit was then cleared for clinical use.
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Event Description
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It was reported that during inspection by a getinge field service engineer (fse) service in getinge (b)(4) office, the touch panel of the cardiosave intra-aortic balloon pump (iabp) did not respond.There was no patient involvement and no adverse event was reported.
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Search Alerts/Recalls
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