DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Device Fell (4014); Audible Prompt/Feedback Problem (4020)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).During a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered the pump damaged as a result of being dropped.The fse found that the upper display bezel was cracked, the console cover was dented near the rear handle, the rear cover handle mount was pushed in and cutting the pressure hose, and heard a hissing sound emitting from the back of the pump.To fix the issue, the fse replaced the upper display bezel, cover console, upper display hinge cover, and the pressure tube assembly.The fse then performed a calibration, all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was found damaged as result of dropping the pump.Specifically, the upper display bezel was found cracked and the console cover was found dented near the rear handle.It was also reported that the rear cover handle mount was pushed in and cut the pressure hose.Further, it was reported that a hissing sound was heard emitting from the back of the pump.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was found damaged as result of dropping the pump.Specifically, the upper display bezel was found cracked and the console cover was found dented near the rear handle.It was also reported that the rear cover handle mount was pushed in and cut the pressure hose.Further, it was reported that a hissing sound was heard emitting from the back of the pump.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer reported that the damage to the iabp was the result of the customer dropping the iabp.The pressure hose was cut inside the iabp as a result of this damage.
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) was found damaged as result of dropping the pump.Specifically, the upper display bezel was found cracked and the console cover was found dented near the rear handle.It was also reported that the rear cover handle mount was pushed in and cut the pressure hose.Further, it was reported that a hissing sound was heard emitting from the back of the pump.There was no patient involvement, and no adverse event reported.
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