DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-53 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.Fse found that the signal cable, display to vdo receiver and pcb, vdo receiver are damaged causing the frequent flickering of lines on the screen.Damaged parts must be replaced before the device can function normally.Customer has made a quotation for spare parts.Fse is currently in the process of approving repairs.Device still cannot be returned to customer.A supplemental report will be submitted if this information is provided to us.
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Event Description
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It was reported during a routine check that the cs100 intra aortic balloon pump (iabp) screen flickers in stripes.There was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h10, h11.Corrected fields: g1(contact person).Fse returned and replaced pcb,color video receiver and cable,display to video rcvr bd.Unit has been returned to customer for clinical use.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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Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d1, d4 (udi#), g1(contact person).
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