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 Problems
Component Incompatible (1108); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) that encountered the issue during installation of a new safety disk sn (b)(4), reported that failed several times the membrane leak check portion of the pneumatic interface module leak test.To resolved the issue, the fse installed a new safety disk sn (b)(4) and pim leak test passed.The fse completed the full pm and unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.The name of the initial reporter has been abbreviated due to field character limit; the full name should read: (b)(6).
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Event Description
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It was reported that during a new safety disk replacement, performed by a getinge field service engineer (fse), the out of box (oob) safety disk was discovered to be defective.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, d10, g4, g7, h2, h10.The maquet national repair center (nrc) wayne received the defective part for failure investigation.A senior repair technician of the national repair center (nrc) inspected the safety disk, drive side per the cardiosave service manual with no visual damage observed.The technician installed the safety disk into the cardiosave test fixture and tested the disk to factory specifications per procedure and the cardiosave service manual.The membrane differential test results read 9mmhg, the factory specification is 6mmhg.The nrc verified the failure of the disk failing the membrane leak test.The disk failed testing.Sending the safety disk to the cardiosave production department for failure analysis per procedure.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, h2, h10.The national repair center received the safety disk serial number from the getinge production department.Production verified the failure of the safety disk failing the membrane leak test.The safety disk failed testing.Nrc will retain the disk in the national repair center per procedure.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 safety disk replacement performed by a getinge field service engineer (fse), the new safety disk consistently failed the membrane leak check portion of the pneumatic interface module leak test.There was no patient involvement.
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Search Alerts/Recalls
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