DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problems
Failure to Charge (1085); Detachment of Device or Device Component (2907); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that during pre-use, the cardiosave intra-aortic balloon pump (iabp) units power button cover fell off, batteries are dead unit is shutting off by itself.Later it was clarified with biomed that the on/off button fell off and both batteries are depleted and they are not charging.There was no patient harm reported.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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A getinge field service engineer (fse) says able to reproduce, not able to power on.Replaced cable power on switch,also found depleted batteries showing install 1980,so replaced batteries li-ion.Full calibration, functional testing and safety check to factory specifications.Unit returned to the customer.
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Event Description
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N/a.
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Search Alerts/Recalls
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