DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-52 |
Device Problems
Misconnection (1399); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a routine check, the battery in the cardiosave intra-aortic balloon pump (iabp), got stuck in the charging station, when it was unlocked.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge service engineer was dispatched to evaluate this unit and found the battery was not coming out once it was unlocked.The service engineer enlarged the connection point of the battery to make the connection between the battery and machine loosen a bit.After adjustment, the battery was able to eject out every time when it was unlocked.The service engineer reported that the battery was functioning.In addition, the charging function was checked and it was normal.The machine was then returned to customer for clinical use.A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Updated fields; b4, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: d5, g1, h6 (medical device ¿ problem code).
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Event Description
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N/a.
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