DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-55 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the pcb, motor controller.The machine can be used normally.A supplemental report will be submitted upon completion of our investigation.The event site address was shortened due to the character limits.The event site address line 2 should read: (b)(6).
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Event Description
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It was reported that before use the cs100 intra- aortic balloon pump (iabp) alarmed for a electrical test fails # 50 (motor speed out of specification).There was no patient involvement, and no adverse event was 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, d9, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: d1, d4 (version or model #, catalog #).
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