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
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Communication/interviews: a getinge field service engineer (fse) has conversed with the customer and was advised that the batteries were not charging.The fse requested for the customer to make sure the console was secured into the units cart to charge the batteries, the customer confirmed that they were not secured in the console, he installed the console to the cart and the charging sequence started.The customer called the fse and cancelled the service call stating that everything was fine and confirmed that it was a user error.A supplemental report will be submitted upon completion of our investigation.The full event site name in is (b)(6).Device not returned to manufacturer.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) battery was not charging.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event 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, g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).
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Search Alerts/Recalls
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