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
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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During a preventative maintenance (pm) service, the getinge field service engineer (fse) bent one of the pins on the front end board connection, he ordered the front end board for replacement.He returned to finish the repair/pm and replaced the front end board and completed all diagnostic, performance and safety tests on the unit during pm.The unit was then approved for clinical use and returned to the department.A supplemental report will be submitted upon completion of our investigation.(b)(6).The initial reporter named is a getinge employee who has different contact details from that of the event site.(b)(6).
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Event Description
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It was reported that while completing a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the gfe noticed loose connectors on the front end board, so he removed it to tighten the connectors.While reinstalling the front end board he bent one of the pins on the board connection.There was no patient involvement, and no adverse event reported.This report is being submitted for the bent pin.A separate report, 2249723-2021-02482, has been submitted for the loose connectors issue.
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Event Description
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It was reported that while completing a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the fse noticed loose connectors on the front end board, so he removed it to tighten the connectors.While reinstalling the front end board he bent one of the pins on the board connection.There was no patient involvement, and no adverse event reported.This report is being submitted for the bent pin.A separate report, 2249723-2021-02482, has been submitted for the loose connectors issue.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: b5, g1(contact person).
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