DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problems
Device Displays Incorrect Message (2591); 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 10/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Type of investigation not yet determined: additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.The full name of the initial reporter that is abbreviated is (b)(6).
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) displayed a "iab disconnected" message.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Device not accessible for testing (4117/3233): the getinge field service engineer called the customer to schedule service and reported that the customer's biomed cancelled the call.The fse was informed that the iabp unit had been released for clinical use.Communication/interviews (4111/3233): the customer's biomed reported that no repair was performed on the iabp unit and that the iabp unit was operational and had been cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.H3 other text : not returned to manufacturer.
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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(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d5, g1(contact person).
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Search Alerts/Recalls
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