DATASCOPE CORP. - MAHWAH CS100,ENGLISH,NON-UTS,INTL; 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 12/13/2023 |
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 that during a routine check, the cs100 intra-aortic balloon pump (iabp) unit's electrical test fails code # 50.There was no patient involved.
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Manufacturer Narrative
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Additional fields: e1(event site state:25, event site postal code: (b)(6).) it was reported that cs100 intra-aortic balloon pump (iabp) electrical test fails code 50#.Getinge field service engineer (fse) found checked and found same problem , and problem is iabp showing error - electrical test fail code # 50.After inspection found pcb motor control ( part no - d671-00-0004) defective.So need to be replaced.Despite gfes (good faith efforts), no response has been received regarding any repair or the status of the iabp.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.No patient involvement.
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