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 Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the reported issue.The fse replaced the spring coil located in the back of battery slots.After the replacement of springs, the batteries continued to fail and auto eject from the battery slot.The fse returned onsite at a later date and replaced the power slot board.After replacement of the board, the batteries no longer adhered to the slot when the battery latch was unlocked.The fse verified and calibrated the unit.The unit passed all functional and safety tests per factory specifications.The unit was then returned to the customer and cleared for clinical use.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had batteries that were not ejecting from the battery slot when unlocked.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
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Event Description
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It was reported that during a routine check, the batteries for the cardiosave intra-aortic balloon pump (iabp) were not ejecting from the battery slot when unlocked.There was no patient involvement, and no adverse event was reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, e1 (site country), e2, e3, g3, g6, h2, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10, h11 corrected fields: h6 (component codes).
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