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
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), that the cardiosave intra-aortic balloon pump (iabp) unit failed drive manifold deep vac test.There was no patient involvement, and no adverse event reported.Unit failed drive manifold deep vac test.(rrso) unit failed drive manifold deep vacuum test.No patient involvement or harm.Issue found during regularly scheduled pm maintenance.Issue found by getinge tech (b)(4).Yes issue affected performance.Yes getinge provides regular scheduled service.(b)(4).Cardiosave hybrid type b plug.(b)(4).Technicians remarks: replaced drive manifold assembly.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer= and cleared for clinical use.(b)(4).Issue found during pm cycle by getinge tech (b)(4).No patient involvement or harm.Yes performance was affected by a bad drive manifold* yes regular maintenance is performed by getinge, last pms where 4/2021.* the defective drive manifold was disposed of at the facility.
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Manufacturer Narrative
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(b)(6).The getinge field service engineer (fse) reported that while performing preventive maintenance, the unit failed drive manifold deep vac test.The getinge field service engineer (fse) replaced the drive manifold assembly and the muffler <100 micron.The unit passed all calibration, functional and safety tests performed then returned to customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.
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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: b5, g1(contact person).
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), that the cardiosave intra-aortic balloon pump (iabp) unit failed drive manifold deep vac test.There was no patient involvement, and no adverse event reported.
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