DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problems
No Display/Image (1183); Display or Visual Feedback Problem (1184)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
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.The screen was cleared by the customer prior to the arrival of the fse.The reported issue could not be replicated during the preventative maintenance (pm).The internal display connections were checked for tightness and alignment.The unit passed all functional and safety tests to factory specifications.The unit was cleared for clinical use.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 the cs300 intra-aortic balloon pump (iabp) screen was blank and displayed lines on it.The customer suspected the screen to be broken.There was no patient involvement, and no adverse event was reported.
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Search Alerts/Recalls
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