DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-55 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Type of investigation not yet determined: the defective power supply was requested to be returned to the national repair center for further investigation.A supplemental report will be submitted when our investigation is completed.The initial reporter is a getinge authorized representative who has different contact details from that of the event site.A contact telephone number at the event site is (b)(6).
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Event Description
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It was reported that during a service repair (mfg report number 2249723-2021-01949) performed by a getinge authorized distributor's field service engineer (fse), in an attempt to installed a new power supply, when the fse removed the new power supply sn#(b)(4) from the packaging, it was realized that the chassis/enclosure of the power supply was bent and it had a loose rivet.This is a failure during an installation.There was no patient involvement, and no adverse event reported.
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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 authorized distributor's field service engineer (fse) in relation to a separate and unrelated issue, the fse attempted to install a new power supply.However, when the fse removed the new power supply from its packaging, he found the chassis enclosure of the power supply was found bent and had a loose rivet.This is a failure during an installation.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, d9, g2, g3, g6, g7, h2, h3, h4, h6, h10, h11 corrected fields: b5, d1, d4, e1.A getinge authorized distributor's field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The iabp needed a power supply replacement due to faulty fan.In an attempt to install a new power supply, the fse noted that the chassis/enclosure of the new power supply was bent and it had a loose rivet.The iabp was then taken to the fse's facility to await repair.The fse replaced and installed a new power supply in the iabp to resolve the issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.
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