DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/3233) : a getinge field service engineer (fse) evaluated the unit and determined the pneumatic interface module (pim) requires repair.The fse advised the pim part is on back order.A supplemental report will be submitted upon receipt of additional information.
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Event Description
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It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a loose pneumatic interface module (pim) connector.There was patient involvement, thus no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the unit and determined the pneumatic interface module (pim) requires repair.The fse advised the pim part is on back order.A supplemental report will be submitted upon receipt of additional information.
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Event Description
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It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a loose pneumatic interface module (pim) connector.There was patient involvement, thus no adverse event reported.
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Manufacturer Narrative
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The getinge field service engineer (fse) returned to the customer's site and installed a new pneumatic module assembly (pim).The installation of the part repaired the reported issue.Subsequently, the fse completed preventative maintenance (pm) service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The suspected faulty pim is expected to be returned for failure investigation.A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Updated fields - b4,e1(site country),e2,e3,g3,g6,h2,h4,h6(type of investigation, investigation findings, investigation conclusions),h10,h11.Corrected field - d5,g2.
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Event Description
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N/a.
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Search Alerts/Recalls
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