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
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2024 |
Event Type
malfunction
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) customer called stating the printer stopped working, printing strips suddenly.All attempts at resuming print function are unsuccessful.Customer stated they will change pump.There was no patient harm reported.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Event Description
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N/a.
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Manufacturer Narrative
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Based on the communication provided there was no response from the customer after attempting to obtain the additional information.Therefore, no root cause evaluation can be performed.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.H3 other text : customer denied service / did not provide information.
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Search Alerts/Recalls
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