DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problems
Device Emits Odor (1425); Overheating of Device (1437); Output Problem (3005)
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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 05/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device(10): a getinge field service engineer (fse) was dispatched to evaluate this unit.The issue with the unit was recognized as a printer issue, the unit had spare parts tested and swapped out for replacement.The unit was then tested with the replacement parts and the issue had resolved the unit produced no smell and was able to count time and print.The machine was test ran for two days with no repeat issues, the unit was functioning normally with no warning messages presented.A supplemental report will be submitted upon completion of our investigation.(b)(6).
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Event Description
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It was reported that while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) printer would not print.It was also reported that the unit was hot and they smelled burning.There was no death, injury or adverse event 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,e1(site country),g3,g6,g7,h2,h4,h6(type of investigation, investigation findings, investigation conclusions),h10.
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Search Alerts/Recalls
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