DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-68 |
Device Problems
Circuit Failure (1089); Failure to Power Up (1476)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2023 |
Event Type
malfunction
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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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It was reported, the cs300 intra-aortic balloon pump (iabp) internal short circuit equipment.It does not turn on and it is burning all the fuses that are installed in it.
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Event Description
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It was reported that before use, the cs300 intra-aortic balloon pump (iabp) unit had an internal short circuit equipment, does not turn on and is burning all fuses that are installed in it.There was no patient involvement.
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Manufacturer Narrative
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At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.
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Search Alerts/Recalls
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